and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Cancer Institute (NCI) |
|
Funding Opportunity Title |
NCI Community Oncology Research Program (NCORP) Research Bases (UM1) |
Activity Code |
UM1 Multi-Component Research Project Cooperative Agreements |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-CA-13-012 |
Companion Funding Opportunity |
|
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.393, 93.394, 93.395, 93.399 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) solicits applications from institutions/organizations to participate in the National Cancer Institute's Community Oncology Research Program (NCORP) as NCORP Research Bases. The goal of NCORP is to build upon the scope and activities of NCI's previously supported community networks, the Community Clinical Oncology Program (CCOP) which includes CCOP community sites (CCOPs), Minority-Based CCOP sites (MB-CCOPs), and CCOP Research Bases, and NCI's Community Cancer Centers Program (NCCCP) by establishing a single community-based research program. NCORP will be an integrated national network to: 1) design and conduct cancer prevention, control, and screening/post-treatment surveillance clinical trials; 2) design and conduct cancer care delivery research; 3) enhance patient and provider access to treatment and imaging clinical trials conducted under the reorganized National Clinical Trials Network (NCTN); and 4) integrate disparity research questions into clinical trials and cancer care delivery research. NCORP will consist of three components, each with its own FOA: NCORP Research Bases (covered by this FOA); NCORP Community Sites; and NCORP Minority/Underserved Community Sites. The NCORP Research Bases will design and conduct cancer prevention, control, and screening/post-treatment surveillance clinical trials and studies on cancer care delivery as well as manage and analyze the data and report the research results. |
Posted Date |
November 8, 2013 |
Letter of Intent Due Date(s) |
December 8, 2013 |
Application Due Date(s) |
January 8, 2014 |
AIDS Application Due Date(s) |
January 8, 2014 |
Scientific Merit Review |
March-April 2014 |
Advisory Council Review |
May 2014 |
Earliest Start Date |
September 2014 |
Expiration Date |
January 9, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and NIH’s Applying Electronically website for more information.
Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This Funding Opportunity Announcement (FOA) is one of three FOAs that implement the NCI Community Oncology Research Program (NCORP). The overall goal of NCORP is to bring cancer clinical trials, as well as studies on cancer care delivery, to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes and a reduction in cancer disparities. NCORP is expected to interact with the main NCI-supported clinical trial program, the NCI National Clinical Trials Network (NCTN).
Note: The NCTN structures are evolving from the current main clinical trials program, the NCI Clinical Trials Cooperative Groups. Because not all awards for the NCTN components may be in place at the time of NCORP application submission, the further text related to FOA requirements provides dual references, e.g., "Clinical Trials Cooperative Groups or NCTN Operations Centers".
The NCORP will support the following components that will be individually awarded through the respective FOAs indicated below:
NCORP Research Base is defined as a research hub for the NCORP program. Research Bases must be located at leading institutions with comprehensive expertise in cancer clinical trials, such as institutions that are cancer foundations, healthcare research organizations (including sites of Clinical Trials Cooperative Groups or NCTN Group Operations Centers), NCI-designated Cancer Centers, or integrated healthcare systems. These institutions must have an established organizational structure for the design and conduct of multi-center cancer prevention, control and screening/post-treatment surveillance clinical trials and cancer care delivery research. The Research Base provides scientific and statistical leadership for developing, implementing, and analyzing multi-institutional cancer prevention, control, and screening/post-treatment surveillance clinical trials, quality-of-life studies embedded within treatment and imaging clinical trials and studies on cancer care delivery. The Research Bases will be responsible for study operations and data management, including timely protocol development, compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements, audits, training, quality assurance, and site support.
NCORP Community Site is defined as a consortium of community hospitals and/or oncology practices or a community-based integrated healthcare system that accrues participants to: 1) cancer prevention, control, and screening/post-treatment surveillance clinical trials designed and conducted by the NCORP Research Bases; 2) NCTN-sponsored cancer treatment and imaging clinical trials, as well as quality-of-life studies embedded within them; and 3) cancer care delivery research where participants can be defined as patients, practitioners, and/or healthcare organizations.
NCORP Minority/Underserved Community Site is defined as a consortium of community hospitals and/or oncology practices, a public hospital, or academic medical center that has a patient population comprising at least 30% racial/ethnic minorities or rural residents and accrues participants to: 1) cancer prevention, control, and screening/post-treatment surveillance clinical trials designed and conducted by the NCORP Research Bases; 2) NCTN-sponsored cancer treatment and imaging clinical trials, as well as quality-of-life studies embedded within them; and 3) cancer care delivery research where participants can be defined as patients, practitioners, and/or healthcare organizations.
This FOA solicits applications specifically for NCORP Research Base awards. Applicants interested in other NCORP components must use an appropriate companion FOA.
Although cancer clinical research has traditionally been conducted at academic medical centers, the bulk of cancer care takes place in the community setting. Expanding clinical research beyond the academic environment allows access to a larger and more diverse patient population treated in a variety of real-world healthcare delivery settings, which can accelerate accrual to clinical trials, allow for feasibility testing of promising new interventions in variable care environments, and increase the generalizability and relevance of study findings. Engaging community oncologists in collaborative research can also facilitate the uptake of effective, evidence-based practices into routine care.
In recognition of the importance of community-based clinical research, three decades ago, the NCI launched the Community Clinical Oncology Program (CCOPs, MB-CCOPs, and CCOP Research Bases) to form a clinical trials network to expand patient and physician access to cutting-edge cancer treatment clinical trials outside of traditional academic medical settings, as well as develop multi-institutional cancer prevention, control and screening clinical trials as well as health-related quality of life studies. In the years since, the CCOP network has become a key component of the national cancer clinical trials enterprise, contributing a substantial proportion of accrual to phase 2 and 3 treatment and imaging clinical trials with significant representation of minority patients, and implementing a series of pivotal and influential multi-institutional clinical trials in cancer prevention, control, and screening. In 2007, the NCI s Community Cancer Centers Program (NCCCP) was initiated to explore ways in which community hospitals could enhance access to care, improve the quality of care, and expand research across the entire cancer continuum with a focus on diverse racial, ethnic, and underserved populations.
Strong clinical trial programs remain essential to address the many unmet needs in cancer prevention, control, screening, and treatment. Yet findings from health services research and the promising role of quality improvement initiatives underscore the critical, complementary role of care delivery structures, processes, and organizational policies as determinants of patient care experiences and outcomes. Systematic studies and improvement of these factors are important in assuring that all patients, specifically those from minority/underserved populations, benefit from the best available knowledge about cancer prevention, control, screening/post-treatment surveillance, and treatment.
The importance and influence of cancer care delivery on patient care have led to the emergence of cancer care delivery research as a multidisciplinary field of scientific investigation that studies how complex, multi-level forces including social factors, financing systems, organizational structures and processes, health technologies, provider and individual behaviors affect cancer outcomes, access to cancer care, the quality and cost of cancer care and ultimately the health and well-being of cancer patients and survivors. Its focus includes individuals, families, organizations, institutions, providers, communities, populations, and their interactions. As the bulk of cancer care occurs in a community setting, community-based care organizations must be a key focus of cancer care delivery research that seeks to understand and improve patient outcomes based on these factors.
NCORP, while maintaining a vigorous program for the design and conduct of cancer prevention, control, and screening clinical trials and participation in NCTN treatment and imaging clinical trials, will expand the scope of activity to include cancer care delivery research. An important component of NCORP will be research on the diverse and multi-level factors that affect access to and quality of care in the community and also increase the focus on minority/underserved populations that are underrepresented in clinical trials and for which cancer care delivery issues are of great importance.
During the start-up and initial phase of NCORP, the expected relative balance in the level of effort between clinical trials and cancer care delivery research will be approximately 90% and 10%, respectively for a given Research Base and this is reflected in the FOA funding estimates. However, funding from other sources can be used to augment the cancer care delivery research efforts.
To address these goals, it is anticipated that NCORP awardees will focus on the following activities:
The current CCOP agenda for clinical trials is expected to be continued under NCORP as its predominant activity. Specifically, the NCORP agenda is expected to include the following aspects:
New areas of special emphasis will include studies addressing mechanisms of cancer symptoms and treatment-related toxicities, observational or longitudinal studies to understand the natural history of cancer symptoms and treatment-related toxicities, molecularly targeted agents to understand toxicities, post-treatment surveillance, underdiagnosis and overdiagnosis, and management of precancerous lesions. Post-treatment surveillance studies will evaluate the use of optimal screening modalities or tumor markers designed to detect recurrences of cancers following curative intent. Methods of diagnosis for cancers will be collected within NCORP trials to facilitate the collection of data required to evaluate over and under diagnosis of cancers (e.g., screening interval breast cancers).
NCORP will also build an infrastructure and research agenda for cancer care delivery research that includes the following:
The NCORP cancer disparities research agenda will integrate into clinical trials and cancer care delivery research, as appropriate, the following:
NCORP’s operating approach will share the principles underlying the transformation of the national cancer clinical trials enterprise and the creation of the NCTN. Essential features include:
Interactions with Other NCI-supported Programs: In addition to the three key components of NCORP which will be directly funded by the NCORP, other NCI-supported research programs and their awardees will have important supporting roles in achieving the research objectives of the NCORP. The NCORP awardees will be expected to interact with such entities/programs as the NCTN, the NCI Clinical Trials Tumor Banks, the NCI Cancer Trials Support Unit, the pediatric and adult NCI Central Institutional Review Boards (CIRBs), research programs of NCI’s Center to Reduce Cancer Health Disparities, and NCI Advisory and Scientific Committees including the NCI Scientific Steering Committees.
Program Evaluation: NCORP will be subject to external evaluation (to be coordinated by NCI Program Staff) near the end of the project period. Such evaluation is part of NIH efforts to optimize the efficiency of funded research.
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New The OER Glossary and the PHS 398 Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The National Cancer Institute intends to commit an estimated total of $42.9 million ($38.3 million for cancer clinical trials and $4.6 million for cancer care delivery research) for up to seven (7) awards in FY 2014. Future year amounts will depend on annual appropriations. |
Award Budget |
Application budgets are not limited, but need to reflect the actual needs of the proposed project. Because the nature and scope of the proposed research will vary from application to application, the size of each award may also vary . |
Award Project Period |
5 years |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Additional Eligibility provisions:
Institutions not eligible to apply include:
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Each applicant organization may submit only one application in response to this FOA...
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Worta McCaskill-Stevens, M.D., M.S.
National Cancer Institute (NCI)
9609 Medical Center Drive, Room 5E502, MSC 9785
Bethesda, MD 20892-9785 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (240) 276-7050
Email: [email protected]
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:
Referral Officer
National Cancer Institute (NCI)
9609 Medical Center Drive, Room 7W412, MSC 9750
Bethesda, MD 20892-9750 (for express mail, use Rockville, MD 20850)
Telephone: (240) 276-6390
Email: [email protected]
All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements.
Research Strategy must consist of the following sub-sections with the indicated page limits:
A. Research Base Overview and Leadership - 12 pages
B. Cancer Prevention, Control and Screening Clinical Trial Development Program - 12 pages
C. Statistical Analysis/Data Management for Cancer Prevention, Control and Screening Clinical Trials - 12 pages
D. Cancer Care Delivery Research Program - 12 pages
E. Operational Management - 12 pages
F. Collaboration and NCORP Collective Management - 6 pages
The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a UM1 application.
Face Page
All instructions in the PHS 398 Application Guide must be followed,.
Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells
All instructions in the PHS 398 Application Guide must be followed,.
Table of Contents
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Modify the Table of Contents to include the required sub-sections of Research Strategy:
A. Research Base Overview and Leadership
B. Cancer Prevention, Control, and Screening Clinical Trial Development Program
C. Statistical Analysis/Data Management for Cancer Prevention, Control, and Screening Clinical Trials
D. Cancer Care Delivery Research Program
E. Operational Management
F. Collaboration and NCORP Collective Management
Detailed Budget for Initial Budget Period
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Applicants should provide an itemization showing for each expense category how the initial period budget is divided between Clinical Trials Program expenses and expenses for Cancer Care Delivery Research Program.
Applicants may visit the NCORP website at http://prevention.cancer.gov/ncorp for a worksheet that may help them complete the application budget section.
Budget for Entire Proposed Period of Support
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Applicants should provide within the budget justification an itemization showing for each expense category how the entire period budget is divided between Clinical Trials expenses and expenses for Cancer Care Delivery Research.
NOTE: Requests for funds should reflect costs associated with the design and development of cancer prevention/control clinical trials and cancer care delivery research studies. The request should also reflect operations/statistical costs for quality control and data management costs for NCORP Community and Minority/Underserved Community Site participation in clinical trials based on the expected accruals and for other member institutions accruals in cancer prevention and control clinical trials. Operations/statistical costs for cancer care delivery research also should be included. NCORP-Research Base affiliation agreements must be included. Each application should include a budget for monitoring and auditing activities. Funding can be requested for scientific development and pilot testing of new cancer prevention and control and cancer care delivery research initiatives (including support of a cancer prevention and control committee(s) for the Research Base), and for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops).
Biographical Sketch
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Resources
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: In this section provide documentation of important capabilities and available resources as indicated for specific functional components of the NCORP Research Base listed below. Relevant information may be provided in tabular form as listed below. Applicants are strongly encouraged to use, as appropriate, table templates provided at http://prevention.cancer.gov/ncorp.
Table 1 - Title Key Leadership Staffing As of Date of Application Preparation
Table 2 Primary Scientific Achievements for Clinical Trials by Category, Phase & Number from 6/1/08 5/31/13
Table 3 Cancer Prevention and Control Concepts in Development & Under Review
Table 4A Summary Accrual for Currently Open Clinical Trials
Table 4B Summary Accrual for Closed Clinical Trials
Table 5 Cancer Care Delivery Research Study Accomplishments
Table 6 Summary of General Data Timeliness for Open Cancer Prevention & Control Clinical Trials Led by Applicant Research Base 6/1/08 5/31/13
Table 7 Summary of Onsite Auditing Activity for Cancer Prevention & Control Clinical trials Over 5-Year Period (2008 2013)
Table 8 Description of Biospecimens Collected in Conjunction with Cancer Prevention & Control Clinical Trials from 6/1/08 5/31/13
Research Plan
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Specific Aims: Outline the Specific Aims of the proposed Research Base, indicating how they fit into the overall goals of the NCORP and the key requirements of the FOA.
Research Strategy:
This section must consist of the sub-sections A-F described below:
Sub-Section A. Research Base Overview and Leadership
In this sub-section, applicants are expected to provide a general overview of the proposed Research Base and describe its features and operations. Include a diagram illustrating the organizational structure and describe how the scientific, operational, statistical and data management components will interact. Outline how the affiliated NCORP Community Sites, NCORP Minority/Underserved Community Sites and other institutional members will be involved (e.g., committee memberships, study chair positions, training programs, authorship on publications, etc.). Describe approaches for facilitating communication and coordination among affiliated NCORP Sites and other members and how the cancer prevention, control, and screening clinical trials program will be coordinated with the cancer care delivery research program.
Describe qualifications and experience in clinical trials design and conduct of cancer care delivery of a designated PD/PI (or multiple PDs/PIs if this option is used) as well as the individuals designated to coordinate cancer prevention, control, and screening/post-treatment surveillance clinical trials and cancer care delivery research, respectively, if different from the PD/PI. Provide information on key leadership staffing including statistical leadership and senior members of the applicant’s research team who will lead its scientific committees regarding the impact of their publications on their field of research expertise and details about their community-based research experience. Describe the scientific expertise of members of the applicant’s multi-disciplinary oncology research team and other professionals such as epidemiologists, statisticians, health economists, health services, behavioral, and disparities researchers who will be involved in the activities of the Research Base.
NOTE: Supplementary information on the applicant’s scientific and statistical leadership may be summarized in the Key Leadership Staffing table as described in the Resources Section above.
Sub-section B. Cancer Prevention, Control and Screening Clinical Trial Development Program
In this sub-section, applicants are expected to address the following aspects.
Research Priorities. Define the overall priorities for development of cancer prevention, control, and screening/post-treatment surveillance clinical trials, including health-related quality-of-life studies embedded in treatment and/or imaging clinical trials (if applicable). Identify disease areas, patient populations (including high risk cohorts and patients predisposed to treatment toxicities), disease-related symptoms, treatment-related toxicities and disparities questions that will be pursued. Research Bases are not required to conduct research in all areas within NCORP clinical trials (cancer prevention, control, screening, and health-related quality of life). Applicants should describe how the overall chosen areas of research priorities reflect the scientific interests and expertise of their research team.
Capabilities and Experience. Summarize the capabilities and experience of the applicant team in successfully developing, organizing, coordinating, and analyzing multi-institutional cancer prevention, control, and screening clinical trials and health-related quality-of-life studies embedded in treatment and/or imaging clinical trials (if applicable), especially in the context of working with community organizations. Outline the most important achievements in these areas over the past 5 years and also list ongoing clinical trials. Applicants should demonstrate their ability to design clinical trials that are feasible to conduct in the community setting and achieve high levels of participation by community physicians and their patient populations including minority/underserved participants.
NOTE: Information on the applicant’s achievements over the prior 5 years and ongoing clinical trials may be summarized in tables as described in the Resources Section above.
Research Directions. Describe an integrated and cohesive research agenda identifying the applicant’s chosen area of focus and highest priority future research directions as well as any clinical trials currently in development. Describe how the proposed research agenda will emphasize clinical trials addressing mechanisms of cancer symptoms and treatment toxicities, observational or longitudinal studies to understand the natural history of cancer symptoms and treatment-related toxicities, molecularly-targeted agents to understand toxicities, post-treatment surveillance, under-diagnosis and over-diagnosis, and management of precancerous lesions. Observational and longitudinal studies may be used in symptom and toxicity management when appropriate to inform and lead to intervention clinical trials. Describe the process for including biospecimen collection in clinical trial design when appropriate and opportunities for developing clinical trials based on the results and experiences from previous clinical trials. Describe the process for ensuring that the clinical trial aims, hypotheses, and designs will be pertinent to community physicians and their patient populations, are feasible to implement in the community, and provide opportunities to evaluate differential outcomes in minority/underserved populations. It is expected that an overall summary of the research agenda will be provided and not detailed descriptions of proposed studies.
NOTE: Information on clinical trial protocols and concepts currently in development or under review may be summarized in a table as described in the Resources Section above.
Scientific Committee(s). Define the proposed scientific committee(s) and their role in the development of the research agenda. Outline the composition and function of each committee as well as the organizational relationship between the various committees, if any. For committees that are not yet formed, outline the purpose, type of expertise sought, and identify potential members of such committees. Describe succession plans and term limits for committee leadership.
New & Junior Investigator Leadership Mentoring/Training. Describe a mentorship/training program for new and junior investigators that provides opportunities for leadership of clinical trials (e.g., developing clinical trial concepts, serving as study chairs, and participation in scientific committees). Outline plans for the involvement of senior members of scientific committees in the mentorship/training program.
Community Site Engagement. Describe plans for engaging NCORP Community Sites and Minority/Underserved Community Sites in the design and conduct of cancer, prevention, control, and screening/post-treatment surveillance clinical trials as well as the mentoring of sites in the capabilities necessary to conduct such clinical trials. Describe plans to foster opportunities for participation on scientific and community oncology committees. Describe the processes for and experience with educating community sites on protocol specific requirements.
Accrual. Provide information on total accrual to cancer prevention, control, and screening clinical trials led by the applicant over the past 5 years. Provide long-term plans for facilitating the recruitment and retention of participants or patients to cancer prevention, control, and screening/post-treatment surveillance clinical trials led by the applicant, including programs or plans for the recruitment and retention of minorities and other underserved populations. In these plans, describe how the Research Base will work with the NCORP Community Sites and Minority/Underserved Community Sites that are or will be affiliated with the applicant, as well as other affiliated members, to facilitate recruitment and retention. In addition, describe the processes for assessing accrual feasibility for proposed clinical trials and for monitoring accrual post-activation and implementing appropriate corrective action plans if accrual is lagging.
NOTE: Information on the accrual to cancer, prevention, control, and screening clinical trials led by the applicant over the past 5 years should be summarized in tables as described in the Resources Section above.
Sub-Section C. Statistical Analysis/Data Management for Cancer Prevention, Control and Screening Clinical trials
In this sub-section, applicants are expected to address the following aspects.
Statistical Analysis. Describe the general approach to statistical design and analysis for multi-institutional cancer prevention, control, and screening clinical trials, including observational and longitudinal studies as applicable. This should include guidelines for interim monitoring and general procedures for sample size estimation for parent and sub-studies, choice of testing and estimation procedures, and handling of missing data. Describe how the statistical team provides leadership in clinical trial design and analysis as well as examples of robust statistical clinical trial designs. Describe how the statistical team participates in Research Base scientific committees and collaborates with study chairs and study teams in clinical trial design and ensuring that final study analyses are performed in a manner to provide timely publication of study and sub-study results and results reporting per NCI and federal regulations. Describe approaches for cross-Research Base collaboration in sharing statistical methodologies, standards, and best practices. The qualifications, experience, and duties of proposed statistical personnel should be described.
NOTE: Formal policies and standard operating procedures for statistical analysis (e.g., guidelines for interim monitoring) should be provided in the Resource section of the application.
Data Management. The applicant should provide a description of data management practices including the flow and review of clinical data following submission from individual institutions/sites. The applicant should describe the data management systems employed, facilities and equipment available, and the information technology support provided for central storage, security, analysis and retrieval of clinical trial data. Descriptions of training for study chairs, site investigators, and site support staff related to data management should be provided. The qualifications, experience, and duties of proposed data management personnel should be described.
Sub-Section D. Cancer Care Delivery Research Program
In this sub-section, applicants are expected to address the following aspects.
Research Priorities. Define the overall research priorities for the development of multi-institutional, community-based cancer care delivery research, highlighting the particular aspects of care delivery and the types of study designs and research methodologies that will be pursued. The applicant should also outline approaches for incorporating health disparities research questions into studies and designing studies specific to hospitals, clinics, and other cancer care settings that serve predominantly minority and/or underserved populations. The envisioned studies may be observational or interventional in design. Observational studies may address the effect of alternative care models on patient outcomes (e.g., patterns of care or service utilization; organizational policies; health behavioral improvement programs; organizational structures such as integrated healthcare systems versus freestanding hospitals). Interventional studies may address implementation of new technologies (e.g., decision-making tools to support genomically-informed diagnostic test or therapies), new approaches for team-based care such as multi-modality therapy planning and delivery, patient navigation and other care processes, and/or incorporation of new types of information (e.g., patient reported information) into clinical decision-making, etc. The applicant should also describe how they will collaborate with other Research Bases to build a coordinated cancer care delivery research program within NCORP and how the cancer care delivery research priorities reflect the scientific interests and expertise of the applicant team. The applicant should also describe the proposed capacity building activities to be undertaken at the beginning of the award (e.g., data systems development, simulation, and training activities).
Capabilities and Experience. Describe the team of cancer care delivery research investigators assembled by the applicant and their capabilities and experience, if any, in developing, organizing, coordinating, and analyzing multi-institutional observational and interventional cancer care delivery research, including experience working with community organizations in conducting such studies. Highlight experience, if any, with conducting studies that incorporate disparities research questions and address minority/underserved populations. Describe how these investigators will work as a cohesive research team, both within the applicant’s Research Base and with other NCORP Research Bases, to develop and conduct cancer care delivery research. Describe plans for recruiting additional cancer care delivery research investigators unaffiliated with the applicant, if applicable. Outline any past cancer care delivery research accomplishments by the applicant team and describe any ongoing cancer care delivery research as well as any studies currently in development.
NOTE: Information on the applicant team’s past accomplishments, if any, in cancer care delivery research and any ongoing studies may be summarized in tables as described in the Resources Section above.
Scientific Committees. Define the proposed cancer care delivery research scientific committee(s) and describe their role in development of the Research Base’s research agenda. Outline the composition, function, and proposed membership of each committee as well as the organizational relationship between the various committees, if any.
Statistical Analysis/Informatics Support. The applicant should describe the general approach and methodologies for statistical design and analysis of the cancer care delivery research envisioned by their research strategy. This description should include procedures for sample size estimation, survey design, handling missing data, multi-level methods for analysis of financial/service utilization data and incorporation of multi-level provider/patient, organization, and system data into study designs. Particular attention should be paid to use of standard statistical methods for multi-site observational and interventional health services and behavioral research studies. Describe the approach for developing a working knowledge of the strengths and weaknesses of the data structures of inpatient/ambulatory data systems (e.g., registries, electronic medical records [EMRs], financial and administrative databases) at NCORP Community Sites and Minority/Underserved Community Sites. The qualifications, experience, and duties of proposed statistical personnel should be described.
NOTE: Formal policies and standard operating procedures for statistical analysis (e.g., guidelines for interim monitoring, survey response rate estimation) should be provided in the Resource section of the application.
Data Management. The applicant should provide a description of proposed methods and approaches for the following:
Developing a working knowledge of the specific inpatient/ambulatory data systems (e.g., registries, EMRs, financial and administrative databases) in place at the individual NCORP component sites participating in cancer care delivery research.
Managing the flow and review of registry, EMR, financial, service utilization and administrative data provided by NCORP Community Sites and Minority/Underserved Community Sites.
Working with other Research Bases to develop and maintain common NCORP-wide repositories of community site data (e.g., cancer registry, processes of care, practice guidelines, organizational policies, provider, facility, organizational and community characteristics).
Data management systems that will be employed, facilities and equipment available and the information technology support provided for central storage, security, analysis and retrieval of registry, EMR, financial, service utilization and administrative data.
Training for study chairs, site investigators, and site support staff related to data management.
The qualifications, experience, and duties of proposed data management personnel should be described.
New & Junior Investigator Leadership Mentoring/Training: Describe the mentorship/training program for new and junior investigators that provides opportunities for leadership of cancer care delivery research (e.g., developing study concepts, serving as study chairs and participation in scientific committees). Outline plans for the involvement of senior members of scientific committees in the mentorship/training program.
Community Site Engagement. Describe plans for engaging NCORP Community Sites and Minority/Underserved Community Sites in the design and conduct of cancer care delivery research as well as the mentoring of sites in the capabilities necessary to conduct such studies. These plans should involve not only oncologists but also primary care and other providers, other professionals (e.g., administrators, care coordinators, genetic counselors) and staff responsible for managing databases (e.g., cancer registries, financial systems, service utilization systems) relevant to cancer care delivery research. These plans should foster opportunities for participation of these individuals on scientific and community oncology committees.
NCORP Cancer Care Delivery Coordination Committee. Representatives from all Research Bases will be expected to form a joint Committee to develop an overall agenda for cancer care delivery research under NCORP. For details see Section VI.2. Cooperative Agreement Terms and Conditions of the Award. Applicants must plan to participate in the activities of this Committee.
Sub-Section E. Operational Management
In this sub-section, address the operational aspects of the proposed Research Base including its governance, policies, and procedures. All these elements are expected to be designed to optimize the applicant's ability to develop, activate, and conduct clinical trials and cancer care delivery research in a timely manner. Specifically, address the following aspects.
Governance. Define the roles and responsibilities of the PD(s)/PI(s), including responsibilities for human subjects in research. If applicable, outline in this sub-section a rationale and the general benefits of choosing a multiple PD(s)/PI(s) approach. NOTE: Applicants designating multiple PD(s)/PI(s) must also complete the dedicated Section of PHS 398 Research Plan "Multiple PD(S)/PI(S) Leadership Plan." Delineate the roles of other key members of the leadership team in terms of scientific, administrative, and/or technical responsibilities, as appropriate, such as any Director of Operations and/or Administrator positions and any Executive/Advisory Committee(s). Outline communication plans, processes for making decisions on scientific directions, and procedures for resolving conflicts. Include succession plans for key leadership positions and policies governing term limits. In addition, describe the policies governing the applicant's financial management as well as affiliation of NCORP Community Sites and Minority/Underserved Community Sites.
Study Operations. Outline operational practices for clinical trials and cancer care delivery research including those for protocol development, development of data collection and extraction tools, regulatory activities, site support, and study specific protocol training for study chairs, site investigators and site support staff. Describe procedures for tracking the timelines for protocol development and activation and complying with any internal or NCI-mandated timelines for study activation.
Study Monitoring/Quality Control. Outline procedures for study monitoring, data quality control and accuracy verification, including auditing. Describe the methods used for active study monitoring, including procedures for accrual and biospecimen collection tracking, assessing subject eligibility and evaluability, ensuring timely medical review and assessment of patient data, monitoring of data quality and timeliness, and resolving issues. Summarize quality and timeliness guidelines for participating sites and guidelines for reporting to the sites on their performance relative to those guidelines. Provide a brief narrative on clinical trial data quality and timeliness for the past 5 years. Summarize the results of clinical trial audits for affiliated CCOP, MB-CCOP, and other institutional members for cancer prevention, control, and screening clinical trials led by the Research Base over the last 5 years.
NOTE: Comprehensive and detailed information on the applicant’s clinical trial data quality and timeliness and summary audit results for the past 5 years may be summarized in tables as described in the Resources Section above.
Site Performance Evaluation. Criteria for affiliation of NCORP Community Sites and Minority/Underserved Community Sites with the Research Base should be described as well as policies and procedures for evaluating performance against those criteria. Policies and procedures for evaluating performance of other Research Base member/affiliate institutions participating in cancer prevention, control and screening clinical trials must be described as well. Describe processes for implementing corrective actions for observed deficiencies.
Standard Tools. Describe utilization of the available, NCI-supported standard tools and services for the conduct of clinical trials including the Common Data Management System (CDMS), Common Data Elements (CDEs) from the Cancer Data Standards Registry and Repository (caDSR), the Regulatory Support System (RSS), the Oncology Patient Enrollment Network (OPEN), the Clinical Data Update Systems (CDUS/CDS), the Expedited Adverse Event Reporting System (AdEERS) and the Common Terminology Criteria for Adverse Events (CTCAE).
Compliance. Briefly describe the applicant’s policies for assuring compliance with NCI, NIH, HHS, and other Federal regulations regarding the following:
Present a plan and demonstrate the ability to adhere to regulations regarding clinical trial registration in the NCI Clinical Trials Reporting Program and in the U.S. National Library of Medicine (NLM)(www.clinicaltrials.gov) along with results reporting, as applicable.
Describe its plan to ensure that results from clinical trials and cancer care delivery research will be published in a timely manner. The applicants should address their compliance with the data sharing policy and making biospecimens from clinical trials accessible to qualified researchers for further research or explain why sharing is not possible. Include the procedures that will be used, a timeline for making the data and specimens available, and how the rights and confidentiality of participants are protected. Information on the use of biospecimens from the applicant’s NCI-supported cancer prevention, control, and screening clinical trials over the last 5 years should be provided.
NOTE: Detailed information on the applicant's formal policies and standard operating procedures for affiliations of NCORP Community Sites and Minority/Underserved Sites, standard tools, compliance, and use of biospecimens from NCI-supported cancer prevention, control, and screening trials over the past 5 years, if applicable, may be summarized in tables as described in the Resources Sections of the application.
Sub-section F. Collaboration and NCORP Collective Management
In this sub-section, address the following aspects.
Research Collaborations
NCORP Collective Management: The NCORP Research Base team will be expected to participate in the collective management of NCORP and must plan accordingly. Activities in the collective management will include but not be limited to the following: meetings of NCI Scientific Steering Committees and associated Task Forces, Planning Committees for scientific Steering Committees, the NCI adult and pediatric Central Institutional Review Boards and/or similar collaborative activities involving other clinical trial networks.
Protection of Human Subjects: In addition to standard items, provide essential details of the processes the consortium has in place for ensuring compliance with regulations for IRB approval and informed consent (compliance with 45 CFR 46) related to research involving human subjects. Cross-reference this description to Sub-section E of the Research Strategy).
Targeted/Planned Enrollment Table: Information on the targeted/planned enrollment for minorities and members of both genders and children, if applicable, should be based on accrual summarized across all diseases for the planned project period, not on a study- or disease-specific basis.
Letters of Support: In addition to standard items, include letters documenting insitutional commitments. Also include letters documenting key relevant collaborations with other programs and investigators.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered on-time is described in detail in the PHS 398
Application Guide.
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
Applications must be postmarked on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NCI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.
The emphasis of this FOA is on the ability of the proposed
Research Base to provide strong, competent, and comprehensive scientific and
statistical leadership for developing, implementing, and analyzing
multi-institutional cancer prevention, control, and screening/post-treatment
surveillance clinical trials, quality-of-life studies embedded within treatment
and imaging clinical trials and studies on cancer care delivery. Integration of
individual functional components and their ability to interact with other NCORP
awardees are particularly important.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the NCORP Research Base to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the NCORP Research Base proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a research infrastructure, such as NCORP Research Base that by its nature is not innovative may be essential to advance a field.
Significance
Does the NCORP Research Base address an important problem or a critical barrier to progress in the field? If the aims of the NCORP Research Base are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the NCORP Research Base? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA: How well can the PD(s)/PI(s) and the entire applicant team provide scientific leadership for multi-institutional cancer prevention, control, and screening/post-treatment surveillance clinical trials? Will these investigators be able to work as a cohesive research team to efficiently and expeditiously develop and conduct NCORP clinical trials? Are the research experience and qualifications of the leadership and scientific committee members appropriate and sufficient for the focus of each committee? Does the team of cancer care delivery investigators assembled by the applicant have sufficient capabilities and experience in developing, conducting, and analyzing multi-institutional cancer care delivery research? Will investigators be able to work as a cohesive team within and with other NCORP research bases to efficiently develop and conduct NCORP cancer care delivery research? If the investigator team needs to be strengthened in any specific area, are appropriate recruitment plans outlined?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the NCORP Research
Base ? Are potential problems, alternative strategies, and benchmarks for
success presented? If the project is in the early stages of development, will
the strategy establish feasibility and will particularly risky aspects be
managed?
If the NCORP Research Base involves clinical research, are the plans for 1)
protection of human subjects from research risks, and 2) inclusion of
minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Cancer Prevention, Control, and Screening Clinical Trial Development Program
(Note: This entire criterion will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately.)
Research Priorities and Directions: How well do the applicant's chosen research areas and priorities reflect an integrated scientific approach to cancer prevention, control, and screening clinical trials including health-related quality-of-life studies embedded in treatment and/or imaging clinical trials? Do the research priorities address important unmet clinical needs? Do the research priorities incorporate disparities questions in diseases for which there are disproportionate burdens?
Quality of Clinical Trials: What is the overall quality of the clinical trials with the stated research (completed, ongoing, in development, or proposed)? Does the applicant team have effective mechanisms for promoting timely presentation and publications of the results of clinical trials and sub-studies? How adequate are the plans for the mentoring and training of new and junior investigators in terms of leadership skills relevant to clinical trials?
Community Site Engagement: Are the plans for engaging NCORP Community Sites and Minority/Underserved Community Sites in the design and conduct of clinical trials likely to be effective and sufficient?
Accrual: Are the plans for recruitment and retention of study participants well conceived and realistic in terms of accrual goals and timeliness? How good are the applicants' systems/procedures to rapidly assess and monitor accrual and implement appropriate corrective actions if accrual is lagging?
Statistical Analysis and Data Management for Cancer Prevention, Control, and Screening Clinical trials
(Note: This entire criterion will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately.)
Statistical Analysis Program: Do the proposed plans demonstrate sufficient understanding of the design and analysis of multi-institutional cancer prevention, control, and screening clinical trials, including observational and longitudinal studies? Are the plans for final study analyses adequate to facilitate timely publication of study results?
Data Management: How well does the applicant define policies and procedures for data management of the cancer prevention, control, and screening clinical trials? How robust are the data management and study monitoring practices for individual institutions/sites and investigators?
Cancer Care Delivery Research Program
(Note: This entire Criterion will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately.)
Research Priorities: How well do the proposed research priorities reflect an integrated scientific approach to cancer care delivery research? How well does the proposed program address health disparity issues and studies involving minority/underserved patient populations? Are the proposed scientific committee(s) appropriate for the initiation of a cancer care delivery research agenda focused on multi-institutional community based studies? How adequate are the plans for the mentoring and training of new and junior investigators in terms of leadership skills relevant to cancer care delivery research?
Statistical Analysis/Informatics Support. Do the proposed plans demonstrate sufficient understanding of design and analysis of multi-institutional observational and interventional cancer care delivery research? Is the approach for developing a working knowledge of the strengths and weaknesses of the data structures of inpatient/ambulatory data systems in the community setting well-conceived?
Data Management: How robust are the data management and study monitoring practices of the proposed Research Base for cancer care delivery for data provided by NCORP Community Sites and Minority/Underserved Sites? How sufficient are the available information technology resources in terms of securing support for central storage, security, analysis and retrieval of data?
Community Site Engagement: Are the plans for engaging NCORP Community Sites and Minority/Underserved Community Sites in the design and conduct of studies on cancer care delivery likely to be effective and sufficient?
Operational Management
(Note: This entire criterion will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately.)
Governance and Operations: Are the organizational structure and the proposed governance and decision-making processes and interactions among the members of the leadership team adequate for achieving effective scientific design and conduct of clinical trials and studies on cancer care delivery? Are the proposed leadership succession plans (including limits for specific leadership functions) clearly defined and appropriate? If the application includes multiple PD(s)/PI(s), is it clear how activities and responsibilities will be carried out among the multiple PD(s)/PI(s) and is the delineation of responsibilities appropriate? Are the policies and procedures for affiliation of NCORP Community Sites, Minority/Underserved Community Sites and other organizations clear and appropriate? Are the operational practices/procedures and tracking of performance for protocol development and data collections appropriate?
Study Monitoring/Quality Control. How robust are the applicant's policies and procedures for study monitoring, data quality control, and accuracy verification, including auditing? How comprehensive and appropriate are the applicant's methods for active study monitoring, including procedures for accrual and biospecimen collection tracking, assessing participant eligibility and evaluability, ensuring timely medical review and assessment of participant data, monitoring of data quality and timeliness, and resolving issues? Are there clear guidelines for institutions/sites related to data timeliness and metrics for data quality? Are there clear guidelines on timely reporting by the Research Base to the institutions/sites of their performance relative to these guidelines? Does the applicant have a strong record of data quality and timeliness?
Standard Tools and Compliance. How extensive and appropriate is the applicants' utilization of standard NCI-supported tools for clinical trials? Are the applicant’s policies and procedures adequate for assuring compliance with all the applicable regulations? How well do the proposed policies and procedures adhere to good practices for conduct of research?
Collaboration and Participation in NCORP Collective Management
(Note: This entire Criterion will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately.)
How useful will be the identified research collaborations for advancing the development of cancer prevention, control, and screening/post-treatment surveillance clinical trials and cancer care delivery research?
As applicable for the NCORP Research Base proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed NCORP Research Base involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the NCORP Research Base proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Cancer Institute, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
Responsibilities
of NCORP Research Base Awardees
The
PD(s)/PI(s) will have the primary responsibility for:
General responsibilities for the conduct of clinical trials. The awardees programmatic responsibilities for the conduct of the research supported under the Cooperative Agreements are described in the section and documents listed below (and subsequent modifications of these documents) that are incorporated by reference as program-specific Terms and Conditions of Award:
Throughout these Terms and Conditions of Award, NCORP Research Base refers to the organizational structure which is composed of the key personnel (including the scientific and administrative leaders of the Center and its scientific research and administrative committees) and the member institutions/sites (including the institution/site physicians and clinical research associates), responsible for implementing clinical trials and cancer care delivery research and collaborating on research goals of the NCORP. In addition, throughout these Terms and Conditions of Award, NCORP Research Base, refers to all of its member institutions/sites no matter how the membership is defined by a particular NCORP Research Base.
General responsibilities of the PDs/PIs of the NCORP Research Bases include the following areas:
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, NIH, and NCI policies and within the limits of any accepted binding NCI/NIH collaborative agreements with biotechnology and pharmaceutical partners and as governed by NCI-approved Data Sharing Plans and NCI-approved review for use of biospecimens collected in association with NCORP clinical trials.
Awardees are allowed to accept funds from non-governmental sources to support NCORP research that is not supported in part or in full by the NCI. These funds are considered Program Income (e.g., additional per case data management funding supplementing the NCI/DCP per case data management funding, support for correlative science studies that use biospecimen or image collections funded by the NCI/DCP for clinical trials under the NCORP and must be reported under the Terms and Conditions of Award for the NCORP Program unless they are associated with an exempted category under the NIH grant policy for program income, available at http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch8.htm#_Program_Income.
All NCORP awardees must report these funds to the NCI on an annual basis (in the non-competing Type 5 application the annual progress report) and must indicate the clinical trial that the funds are being used to support (or other functional component if the funds are not provided to support specific clinical trials). The Terms and Conditions of Award for all the Cooperative Agreements under the NCORP Program define the operational principles under which the awardees must function to ensure the independence of the research conducted regardless of whether program income is or is not available for any of the awards.
The Research Base is responsible for developing and implementing its own Constitution and By-laws. The Constitution and By-laws should define the organizational structure, composition, and specific responsibilities of each Research Base committee (scientific and administrative) as well as study teams and membership for institutions/sites. Integration with the administrative structure of the National Clinical Trials Network (NCTN) is anticipated.
Clinical Trial and Cancer Care Delivery Development Program
Overall Responsibilities for Cancer Prevention and Control Clinical Trials
It is the responsibility of the NCORP Research Base to develop and articulate an overall research strategy related to cancer prevention, control, screening/post-treatment surveillance and health-related quality of life. This includes clinical evaluations of the effectiveness of interventions for the purpose of reducing the risk for developing cancer (including, but not limited to, chemopreventive agents, surgical interventions, and lifestyle modifications); development of risk assessment models; methods for the early detection of cancer and management of precancerous lesions (i.e., screening) or for the earlier detection of cancer recurrence (i.e., post-treatment surveillance); interventions to improve patients quality of life and/or to treat symptoms arising from cancer or toxicities arising from cancer therapy; and ways to improve continuing, palliative, or end-of-life care. Such studies are aimed at reducing cancer incidence, morbidity, mortality, and cancer disparities through the identification, testing, and evaluation of effective and appropriate strategies and interventions.
It is the responsibility of the Research Base awardee, in accordance with its constitution, bylaws, policies, and procedures, to develop the details of the research design, including definition of objectives and approaches, planning, implementation, analysis, publication of results, interpretations, and conclusions of the studies. The Research Base awardee is responsible for statistical leadership for NCORP clinical trials, including developing the statistical research design and analysis plan, statistical analysis, appropriate interim monitoring plans, interpretations, and conclusions in regard to study data.
The Research Base is also responsible for all aspects of data management. It must have Standard Operating Procedures (SOPs) covering all aspects of data management, study monitoring, and data analysis for NCORP studies. The SOPs should include plans for training NCORP investigators and Clinical Research Associates (CRAs) at member participating sites and Study Chairs and Study Teams about their responsibilities for data management and study monitoring. The Research Base must also have the appropriate facilities and equipment, especially with respect to information technology, to provide for complete data management for all aspects of NCORP studies.
Overall Responsibilities for Cancer Care Delivery Research Studies
It is the responsibility of the NCORP Research Base to develop and articulate an overall research strategy related to cancer care delivery. Cancer care delivery research is the multidisciplinary field of scientific investigation that studies how complex, multi-level forces, including social factors, financing systems, organizational structures and processes, health technologies, provider and personal behaviors affect access to cancer care, the quality and cost of cancer care, and ultimately the health and well-being of cancer patients and survivors. Its focus includes individuals, families, organizations, institutions, providers, communities, populations and their interactions. Cancer care delivery research studies may be observational or interventional in design.
Observational studies related to cancer care delivery research include but are not limited to patterns of care or service utilization, alternative organizational structures (e.g. integrated healthcare systems versus free-standing hospitals) or alternative models for implementing multidisciplinary care planning.
Interventional studies include but are not limited to implementation of new technologies (e.g., decision-making tools to support genomically-informed diagnostic testing or therapies), new approaches for team-based care, such as multi-modality therapy planning and delivery, patient navigation and other approaches to evaluate care transitions, and/or incorporation of new types of information (e.g., patient reported information) into clinical decision-making.
It is the responsibility of the Research Base awardee, in accordance with its constitution, bylaws, policies, and procedures, to develop the details of the research design, including definition of objectives and approaches, planning, implementation, analysis, publication of results, interpretations, and conclusions of the studies. The Research Base awardee is responsible for statistical leadership for NCORP cancer care delivery studies, including developing the statistical research design and analysis plan, statistical analysis, appropriate interim monitoring plans, interpretations, and conclusions in regard to study data.
The Research Base is also responsible for all aspects of data management. It must have Standard Operating Procedures (SOPs) covering all aspects of data management, study monitoring, and data analysis for NCORP studies. The Research Base must have the appropriate facilities and equipment, especially with respect to information technology, to provide for complete data management for all aspects of NCORP cancer care delivery research studies. This includes responsibility for maintaining an NCORP repository of data obtained from NCORP Community and Minority/Underserved Community component sites, (e.g. cancer registry data, processes of care data and data on organizational characteristics and policies) and provide repository data per the specifications outlined by the NCORP Research Base Cancer Care Delivery Research Coordinating Committee. The Research Base must also have SOPs for training NCORP cancer care delivery research investigators and Clinical Research Associates (CRAs) at member participating sites and Study Chairs and Study Teams about their responsibilities for data management and study monitoring for NCORP cancer care delivery research studies including standardized training and simulation exercises for medical record abstraction and extraction of data from financial and administrative data systems.
Overall Research Strategy for Disparities Research Studies
NCI defines "cancer health disparities" as "differences in the incidence, prevalence, mortality, and burden of cancer and related adverse health conditions that exist among specific population groups." Disparities research questions must be an identifiable component of a Research Base’s research strategy. Cancer disparities research questions embedded in clinical trials might include randomized recruitment approach among a specific underserved population or pharmacogenomics comparisons between two racial/ethnic populations. For cancer care delivery research, this includes 1) emphasis on research questions involving gaps in access to and quality of care, 2) specialized data collection requirements to support such studies (e.g., SES data collection); and 3) innovative delivery approaches to improve the access to and quality of care.
Scientific Research and Administrative Committees
The Research Base is responsible for establishing scientific research committees and administrative committees for both clinical trials and cancer care delivery research studies and developing a process for the selection of leadership for these committees. The Research Base should ensure that committees involve appropriate representation from relevant stakeholders, including a range of clinical experts, behavioral and health services researchers, and patient advocates. The Research Base is responsible for establishing clear operating principles and procedures for committees and facilitating their operations by arranging meetings and establishing and maintaining electronic communication tools.
Scientific Research Committees: Scientific research committees are defined as committees that function primarily to develop and oversee the conduct of clinical trials and HRQOL and cancer care delivery research studies within a defined strategy (e.g., cancer prevention and control; observational research)
The primary responsibilities of the scientific research committees are to develop study concepts and oversee protocol development and study conduct for approved studies. Through these processes, feasibility of accrual and other types of participation will be considered including minority/underserved accrual and participation will be addressed. Further, the Committees will help develop the Research Base’s overall research strategy including research questions addressing cancer health disparities.
Correlative science studies, especially integral and integrated studies, are increasingly central to the interpretation of clinical trials data, particularly for studies of molecularly targeted agents. Scientific research committees play a key role in the development and conduct of correlative science studies associated with Research Base protocols. Funding for integrated and integral correlative science studies is not provided by the NCORP award (except in exceptional circumstances via an administrative supplement by NCI/DCP for a specific study) but may be applied for via the Biomarker, Imaging, and Quality of Life Studies Funding Program (BIQSFP) for phase 3 and randomized phase 2 trials. Information on the BIQSFP is available at: http://biqsfp.cancer.gov/). Other sources of funding may be sought for correlative science studies that are not eligible for BIQSFP funding (e.g., other NCI and NIH grant funding, industry funding); however, the study must still be reviewed by NCI.
Study Monitoring by Scientific Committees & Study Teams: The primary responsibility for study monitoring resides with the Study Chair, Study Statistician, and other members of the study team that help develop and oversee conduct of a specific study. The relevant scientific research committee is responsible for assuring that the study team is satisfactorily meeting its responsibilities for study monitoring.
Administrative Committees: Administrative committees for clinical trials are defined as committees that provide essential core service functions to help effect other aspects of the Research Base’s research strategy (e.g., Membership, Auditing, Conflict of Interest). Administrative committees responsible for cancer care delivery research also provide essential core services and could include cancer registrars, hospital administration, and financial managers.
Young Investigator Mentoring/Training
The Research Base is responsible for having a mentorship program to involve young investigators in cancer prevention, control, screening, and cancer care delivery research and to help train them eventually to take on leadership responsibilities for trials/studies, and/or committees.
Communications Support
The NCORP Research Base is responsible for organizing and disseminating information about the Research Base’s scientific activities and major changes in administrative policies and procedures to its members through annual or biannual meetings that review the Research Base’s progress, establish priorities, and plan future activities. Additional meetings among Research Base members and meetings with NCI staff may be held as needed. Relevant Research Base responsibilities for meetings include: (a) arranging for appropriate meeting space and accommodations for attendees; (b) developing and distributing meeting agendas; and (c) preparing summaries as appropriate after each meeting for Research Base members and NCI staff.
The Research Base is responsible for establishing routine communication between itself, member sites participating in its studies, and, where applicable, the Cancer Trials Support Unit (CTSU), to facilitate protocol development and study conduct and monitoring. Relevant communication methods include website postings, e-mail, teleconferences, and video-conferences.
Publications
The NCORP Research Base is responsible for ensuring timely preparation and submission of all Research Base publications for peer review. Research Bases must adhere strictly to the publication policy described in these Terms and Conditions of Award.
Acknowledgement of NCI Support and Scope of Publication Policy: Publication or oral presentation of work done via the Research Base’s Cooperative Agreement requires appropriate acknowledgment of NCI support. The definition of publications for this Cooperative Agreement includes NCORP Research Base abstracts, press releases, print-media articles/manuscripts, electronic media articles/presentations, letters, etc., related to findings and results from NCI-sponsored studies. All NCORP Research Base publications must reference the NCI protocol title in the manuscript or abstract title whenever relevant to the publication.
Publication Timelines: Timely publication of NCORP Research Base findings is central to the mission of the Research Base and is a primary means by which the Research Base’s accomplishments can be evaluated. Timely presentation of a study’s findings and results is especially important when a DSMB recommends the public release of this information. Timely presentation of cancer care delivery research study findings and results is especially important when related to public policy and clinical practice standards.
It is expected that preliminary results of major phase 3 trials and large definitive care cancer delivery studies will be presented at a scientific meeting within 6 to 8 months of completion of the study analysis (if not sooner based on the relevance of the results). It is a requirement under the Terms of Awards that a full manuscript on the study results be prepared and submitted for publication in the peer-reviewed literature (not as an abstract) within 1 year of the availability of the primary study results based on the completion date of the study recorded in the U.S. National Library of Medicine database, clinicaltrials.gov. Exceptions to this policy must be approved in writing by the NCORP Director. These timelines may be modified in the future by NCI institute-wide requirements that are in development.
It is also a requirement of these Terms of Award that the results of all NCORP studies be submitted as required by the Food and Drug Administration Amendments Act (FDAAA) Section 801 to comply with the rules defined for inclusion of clinical trial information in clinicaltrials.gov.
Pre-Publication Review:
For cancer care delivery research publications associated with NCI-sponsored NCORP Research Base studies, the NCORP Associate Director must receive a copy of the manuscript or abstract 30 days in advance of publication. No review or comments will be provided unless specifically requested by the Research Base; this is simply a confidential notification. Review timing for publications other than abstracts or manuscripts should be discussed with appropriate NCI/DCCPS staff. No pre-publication review is required for NCORP clinical trial publications.
All press releases issued by the NCI and/or the Research Base on primary study findings and results require review by NCI, NIH, and DHHS. Pre-review timing for press releases on study finding and results must be discussed with and approved by the NCORP Director and Associate Director for all cancer care delivery research studies. Research Bases are encouraged to send drafts of press releases on other topics to NCI for pre-review and/or pre-release notice.
In addition to the requirements listed above, Research Bases should consider carefully whether any findings from clinical trials or cancer care delivery research studies that are pending reporting/publication may have major impact for public health or public policy. If there is the potential for major impact for public health or public policy, the Research Base must inform NCORP Director and Associate Director and work closely with NCI to ensure that the information is released to the public in as timely a manner as possible and in a manner to ensure appropriate communication about the results, including how they may affect other ongoing trials and the treatment of patients on those trials, public policy or current clinical practice.
Post-Publication Reporting & Submission to NIH Manuscript System:
In their competitive Type 1 and non-competing Type 5 applications, Research Bases must report publication references for major clinical trial results and important associated studies to demonstrate the scientific accomplishments of their research strategy. Only references for the manuscripts for key findings should be reported. Copies of manuscripts cannot be submitted as part of the research plan or as appendix material.
Data Rights
The NCI will have access to all data generated under this Cooperative Agreement and may periodically review the data. The awardee will retain custody and primary rights to the data consistent with current DHHS, Public Health Service (PHS), and NIH policies. Pharmaceutical and biotechnology companies will have access to all data generated under DCP Collaborative Agreements; however, the companies may contract directly with the Research Base for access to non-Clinical Data Update System (non-CDUS) data and reports. With respect to cancer care delivery research, external funding agencies and investigators that use the NCORP network to support scientific studies will have access to data from studies funded external to the network (e.g., PCORI and non-profit foundations).
Membership Affiliation(s)
There are two types of NCORP Research Base Member Sites: Community and Minority/Underserved Community Sites and other institutional members. An NCORP Community Site is defined as a consortium of community oncologists from one or more interacting community institutions (e.g., hospitals, practices, integrated health systems) that accrue participants and/or provide secondary data to studies designed and conducted by NCORP Research Bases. The consortium may also include primary care and other providers. A Minority/Underserved Community Site is defined as a consortium of community hospitals, and/or oncology practices, a public hospital, or academic medical center with patient populations comprised of at least 30% racial/ethnic minorities or rural residents, that accrues participants and/or provides secondary data to studies designed and conducted by NCORP Research Bases. Other institutional members may be academic institutions and/or their associated affiliate members.
The Research Base is responsible for establishing, maintaining and monitoring all its members (i.e., Community and Minority/Underserved Community Sites and institutional members) that participate in NCORP trials/studies and credit the Research Base with patient accrual. The Research Base must have a real time , comprehensive, consolidated roster of all its members with their relevant CTEP institution codes, associated investigators and research staff. This roster must be incorporated into the CTSU Regulatory Support System (RSS) for auditing, financial management and crediting of enrollment purposes.
NCORP Research Bases must establish guidelines for Community and Minority/Underserved Community Site awardees and other institutional members to affiliate (i.e., become members). A Research Base must have established affiliation agreements with all member sites participating in that Research Base’s Network.
A Research Base is responsible for providing a portfolio of clinical trials and cancer care delivery research studies, a significant portion of which are feasible to implement in the community setting, are of scientific interest and address the clinical needs of the participating sites populations. Further, a Research Base must provide adequate resources (training, education, data management etc) for the participating sites to implement the studies. A Research Base will require a minimum number of clinical trial accruals by the participating sites that reflect their available studies and resources to conduct them.
Operational Management
Governance, Organizational Structure, Policies & Procedures, and Membership
An NCORP Research Base is responsible for coordinating study proposals, protocol development, protocol submission, study conduct, performance reporting, quality assurance including quality control and study monitoring, protocol amendments/status changes, and adherence (where applicable) to requirements regarding investigational agent management as well as all federal regulations.
The Research Base is responsible for specifying the mix of funding available for a trial/study that it leads prior to trial/study activation (where applicable) as well as for providing information in a timely manner on appropriate modifications in funding on the trial/study during the course of accrual. Specific responsibilities of the Research Base include the following:
Governance: The Research Base is under the leadership of a designated Chair elected by the Research Base’s membership, who coordinates all the scientific and administrative decisions related to Research Base-funded activities and the Research Base’s institutional members. The Multiple Principal Investigator (PD/PI) option is encouraged for the Research Base award given the team science approach of the research effort. Information on the Multiple PDs/PIs Option is available at http://grants.nih.gov/grants/multi_pi/index.htm. If this option is used, the Research Base should designate a Contact PD/PI among the multiple PD/PIs. The designated Research Base Chair (or Contact Principal Investigator under the Multiple PDs/PIs option) is also responsible for all grant-related activities and for communication about these activities with the appropriate NCI/DCP staff.
Organizational Structure, By-laws, and Standard Operating Procedures: The Research Base is responsible for development and maintenance of an organizational structure for the Research Base and its members/sites, including a Constitution and By-laws. The organizational structure of the Research Base should be established with clear and appropriate staff roles and reporting responsibilities, especially with respect to the role and reporting responsibilities of the Research Base Chair (who must also be listed as key personnel in the Research Base application and award). The Research Base is also responsible for the preparation and maintenance of Standard Operating Procedures (SOPs) that cover all aspects of its activities.
The organizational structure should include the Scientific Research and Administrative Committees that the Research Base will need to support its research objectives as well any Executive Committee(s) that the Research Base elects to establish. There should be clearly defined term limits and succession/transition plans for the senior leadership of the Research Base and for the leadership of its committees. Terms for the key scientific leadership positions of a Research Base (e.g., designated Research Base Chair, Committee Chairs, etc.) should be limited to encourage participation by new investigators and to ensure a diversity of views over time. The process for filling elected positions for scientific leadership positions should be well described in the By-laws of the Research Base along with details of any exceptions to term limits.
Development of Concepts, Protocols, and Amendments for NCORP Cancer Prevention, Control, or Screening/Post-treatment Surveillance Clinical Trials or Cancer Care Delivery Research
These procedures apply to cancer prevention, control and screening/post-treatment surveillance clinical trials as well as cancer care delivery research studies except as specifically noted.
The Research Base shall designate Study Chair(s) for each proposed concept/protocol. The Research Base is responsible for establishing policies and procedures for the development and submission of NCORP Research Base study concepts and protocols through the NCI/DCP Protocol Information Office (PD/PIO) for review and approval. The Research Base is also responsible for assembling appropriate study teams for protocol development and for overseeing conduct of approved studies.
Study concepts and protocols (as well as correlative science studies requesting use of biospecimens collected during the conduct of NCORP studies) should be developed, submitted, and implemented in accordance with DCP policies. Research Base SOPs should include timelines for the development of concepts and protocols from initial submission of the concept to NCI through study activation. The SOPs should also include mechanisms for monitoring the performance of the Research Base and Research Base committees and investigators in adhering to these timelines, as well as corrective action plans outlining steps to be taken when these timelines are not met. Data concerning a Research Base s performance in meeting these timelines for concept/protocol development should be provided in its Annual Progress Report. NCI may in the future establish expected timelines for development and activation of NCORP protocols.
Conduct of Cancer Prevention and Control Clinical Trials and Cancer Care Delivery Research Studies
These procedures apply to cancer prevention, control and screening/post-treatment surveillance clinical trials as well as cancer care delivery research studies except as specifically noted.
Specific regulations regarding conduct of NCORP studies include the following:
NCI/DCP Approval Prior to Study Activation and Approval of Protocol Amendments
The Research Base has the responsibility for overseeing conduct of approved studies within its Network regardless of whether the study proposal originates from an investigator within or outside the Research Base.
Since public funds are used to support Research Base studies sponsored under NCORP Cooperative Agreement, no Research Base study using funds supplied under the Cooperative Agreement can be opened without prior approval from the NCI/DCP as communicated in approval letters sent to the Research Base Chair directly from the DCP Protocol Information Office (PD/PIO). The Research Base also is not allowed to expend any NCI funds under this Cooperative Agreement to support any study disapproved by the NCI/DCP. In addition, all protocol amendments must be submitted to DCP’s PD/PIO and be approved by NCI/DCP prior to implementation. Depending on the nature of the amendment, the study may or may not be put on hold to further accrual and/or conduct until the amendment is approved.
Use of the Adult and NCI Pediatric Central Institutional Review Board (not applicable for cancer care delivery research)
All U.S. institutions/sites participating in NCORP cancer control and prevention trials, as members of 1 or more Research Bases, are required to use the pediatric NCI Central Institutional Review Board for any NCORP trial under the pediatric NCI CIRB’s purview. All NCTN treatment trials will use the Adult CIRB unless the site has access to an equivalent IRB.
The NCI may decide, at a future date, to mandate the use of additional NCI CIRB(s) for other types of NCORP trials.
Clinical Trials Reporting Program (CTRP)/clinicaltrials.gov Registration and Outcomes Reporting
All NCORP trials must also be registered and appropriate information updated in the NCI CTRP as described at: http://www.cancer.gov/clinicaltrials/conducting/ncictrp/main as well as registered in the U.S. National Library of Medicine clinical trials database (i.e., at www.clinicaltrials.gov).
Changes in the trial design and accrual as well as results reporting from NCORP trials are also required to be reported in clinicaltrials.gov as required under the Food and Drug Administration Amendments Act (FDAAA), Section 801. The Research Base should ensure information on its NCORP trials is appropriately updated in these systems. Cancer care delivery research studies also may be reported in clinicaltrials.gov as appropriate.
Study Access (not applicable for cancer care delivery research)
Research Bases member institutions/sites will be able to enroll patients on all adult phase 3 trials (and selected phase 2 trials) conducted by NCORP, irrespective of the specific Research Base which is leading the study.
Research Base phase 3 trials (including phase 2/3 studies) using funds supplied under this Cooperative Agreement cannot be conducted under a company IND; all phase 3 IND trials supported, in whole or in part, under this Cooperative Agreement must be conducted under a Research Base IND or a DCP IND. This also applies to phase 3 trials requiring an IDE. Phase 1 and phase 2 trials may be conducted under Research Base or company INDs or IDEs with appropriate monitoring per the Research Base data and safety monitoring plan or Data and Safety Monitoring Board (Data Monitoring Committee) policy for randomized phase 2 trials.
Agents from NCI/DCP Collaborators (not applicable for cancer care delivery research)
All NCORP studies using NCI/DCP-sponsored investigational agents under Collaborative Agreements (such as Cooperative Research and Development Agreements [CRADAs], Clinical Trial Agreements [CTAs], and Clinical Supply Agreements [CSAs]) must be conducted in accordance with the terms of the NCI/CTEP Intellectual Property Option to Collaborators, found on the CTEP website at: http://ctep.cancer.gov/industryCollaborations2/intellectual_property.htmhttp://ctep.info.nih.gov/industry/ipo.html, and the NCI Standard Protocol Language for CRADAs and CTAs. When new avenues of cancer prevention or control involving any investigational agents are pursued, the clinical information obtained in the study should be acceptable to the FDA and other health authorities for inclusion in a possible licensing application. When NCI/DCP and the Research Base contract with the same company (or companies) for support for the same trial (i.e., trials conducted under a NCI/DCP Collaborative Agreement, the Research Base contracts may require review by the appropriate DCP program at the discretion of NCI.
NCORP Required Tools and Services
Research Bases are required to use standard NCORP tools and services for all NCORP trials including, but not limited to: (a) NCTN information system for tracking biospecimen collection from NCTN trials (in development); (b) the NCI Common Terminology Criteria for Adverse Events (CTCAE); and (c) review of all pediatric phase 2 and phase 3 trials by the NCI Pediatric Central Institutional Review Board (CIRB). NCORP Cancer Center Research Bases are expected to use the tools and services by the end of the initial five year funding cycle. Research Bases also will be required to implement standard NCORP data collection tools approved by the NCORP cancer care delivery Coordinating Committee should any be instituted during the NCORP award period.
During the approval process for study protocols and amendments, NCI/DCP ensures that standard NCORP tools and services are used. DCP Cancer Center Research Bases are expected to use NCI tools by the end of the initial five year funding cycle. In addition, Research Base trial protocols will be periodically audited by NCI/DCP to ensure that the tools related to common data elements in compliance with NCORP approved sections of the data dictionary for common data elements in caDSR are used in the data collection instruments for NCORP trials.
It is strongly encouraged that the Cancer Trials Support Unit (CTSU) be utilized for all NCORP trials. NCORP trials using CTSU must also use the NCTN Oncology Patient Enrollment Network (OPEN) and Regulatory Support Services (RSS) for central registration and randomization of patients onto NCORP trials. It is anticipated that all cancer prevention, screening/post-treatment surveillance and control trials will be available on the CTSU at the end of the initial five year funding cycle.
Data Management
The Research Base should establish data management policies and procedures for ensuring data accuracy, timeliness, completeness, and consistency for NCORP studies. The general categories that should be addressed by the data management policies are listed below:
CDUS/CDS Reporting (not applicable for cancer care delivery research)
In addition, data must be submitted in a timely manner on all NCORP trials, as appropriate, to the NCI/DCTD Clinical Data Update System (CDUS/CDS) at http://ctep.cancer.gov/protocolDevelopment/electronic_applications/cdus.htm. Reporting will generally consist of CDUS abbreviated data (primarily demographic and accrual). The Research Base should coordinate activities to ensure information on its NCORP trials is appropriately updated in all these systems.
Collection and Transmission of Data and Biospecimens
All data, as well as any biospecimens collected for an NCORP study must be sent by the institutions/sites participating in the study to the Research Base that is leading the study, unless an exception is approved by the NCI/DCP to accommodate the needs of a specific study. The Research Base is responsible for overseeing the timely collection and transmission of data and biospecimens from all its member institution/sites to NCORP studies for patient accruals that are credited to the Research Base. Collection and banking of tissues and other biological specimens is an increasingly important aspect of the clinical research performed by the Research Bases. For NCORP trials that it leads, the Research Base is responsible for coordinating the acquisition and shipping of protocol-specified tumor specimens and biological fluids (with relevant clinical data) to the appropriate laboratories for testing and to a tumor/specimen repository for storage of specimens for future correlative science laboratory studies. The Research Base is also responsible for ensuring that all its members submit required biospecimens for NCORP studies when the Research Base is credited with the accrual even if the Research Base is not leading the trial.
Data Reporting
The Research Base must have policies and procedures in place to ensure that data reporting requirements are fulfilled in a timely manner including the major data reporting requirements outlined below.
Report of Studies: The Research Base is responsible for providing a semi-annual Report of Studies on all Research Base studies. The Report of Studies should include information detailing participant accrual and demographics, data timeliness, toxicity experienced by study participants, and other items as appropriate, including outcome data as appropriate. The Research Base is responsible for ensuring that electronic copies of the Report are available to NCORP Network members and to the NCORP Director. If a Research Base determines that a Report of Studies is not needed biannually, it must seek approval from the NCORP Director, providing the rationale for this request in writing.
NCI Access to Research Base Website and Data Files Requested by NCI: The Research Base is responsible for ensuring that the NCORP Director and Associate Director have access to the Research Base website, including the member side of the website.
Upon request by the NCI, the Research Base is also responsible for providing true copies of data files and supporting documentation for specific NCI-supported clinical trials and other studies in a timely manner.
Data for Member Performance Evaluations, Audits, & Data Monitoring Safety Boards (DSMBs): The Research Base is responsible for providing accurate and timely reporting of data on accrual, data timeliness, and accuracy, protocol compliance, long term participant follow-up, and audit results related to the conduct of Research Base clinical trials and other studies by member sites for Performance Evaluations of the sites. The Research Base will also provide all data required for member site auditing as well as data evaluation of trials for the Research Base’s Data and Safety and Monitoring Board.
DSMB/DMC Recommendations for NCORP Studies (not applicable for cancer care delivery research)
The Research Base is required to send a listing (or an email with internet access link to a listing) of all Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) recommendations accepted by the Research Base Chair(s) to the NCORP Director after every scheduled DSMB/DMC meeting. DSMB/DMC recommendations accepted by the Research Base Chair(s) after ad hoc DSMB/DMC meetings/calls must also be communicated to the NCORP Director.
Adverse Event Reporting and Patient Safety
At present, sites are not able to submit expedited AE reports through AdEERS for studies without an agent/device/surgery/radiation. The study must have at least one of those intervention types. So at present, behavioral or cancer care delivery research studies are not accommodated in ADEERS or AERS.
The Research Base must establish a system for assuring expedited reporting of all serious adverse events to ensure potential patient safety issues can be identified and addressed quickly. Adverse events should be reported using the Common Terminology Criteria for Adverse Events v4.0 (CTCAE) or most recent version, which is NCI standard language for reporting adverse events in oncology clinical trials and is provided on the NCI/DCTD/CTEP website at: http://ctep.cancer.gov/reporting/ctc.html.
For agents under DCP-sponsored INDs, this involves reporting to DCP via the Adverse Event Expedited Reporting System (AdEERS), or its successor application, according to the guidelines specified in each protocol. Research Bases must also use AdEERS, or its successor application, for expedited reporting of serious adverse events for all NCORP trials (even those not under a DCP IND or not under any IND/IDE) since AdEERS provides reporting pathways for studies that do not include DCP IND agents, as well as pathways for studies that do not include any agents (e.g. surgical only study, radiation only study). Expedited reporting using AdEERS should be performed as described at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/adeers.htm. Serious adverse event reporting for all NCORP trials should also follow the NCI Guidelines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP and CIP) and DCP INDs and IDEs available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf
In addition, for any study using agents under a DCP-sponsored IND, any increase in the incidence of expected toxicities and any plans to change a trial design or close a trial early due to toxicity should immediately be discussed with DCP before any action is taken. For NCORP studies that are not being conducted under a DCP IND, any major patient safety issues (e.g., study closure/suspension for adverse events, inappropriate randomization of patients to treatment arms, etc.) also require immediate notification to DCP before any action is taken.
In general, for studies with these types of immediate safety issues that are under monitoring by a Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) immediate notification should be made to the DSMB/DMC Chair and the NCORP Director. Immediate notification for studies not under DSMB/DMC monitoring should be made to the NCORP Director.
Early Trial Closure
The Research Base must establish policies and procedures for early closure of studies in conjunction with the associated DSMB. The Research Base should explicitly describe the policies in place for phase 2 and phase 3 studies. Statistical guidelines for early closure should be presented as explicitly as possible in the protocol in order to facilitate decisions regarding early closure. NCI/DCP have approved early stopping guidelines for slowly-accruing phase 2 and 3 studies for NCORP. If accrual is behind expectations for a specific study, the Research Base should involve the appropriate NCI/DCP and DCCPS staff in discussions about possible ways to enhance accrual in order to avoid study closure.
Quality Assurance and Onsite Auditing
The Research Base is responsible for establishing mechanisms to assure the accuracy and reliability of the Research Base’s study data. Quality assurance is a complex undertaking spanning the entire range of studies conducted by the Research Base including but not limited to: observational, survey research, registry, administrative, screening/post-treatment surveillance, biomarker, omics, diagnostic, interventional, and imaging. Key items that should be addressed in a Research Base’s quality control procedures include the following:
Study Monitoring
The Research Base is responsible for overall organization and oversight of study teams that monitor data from specific research studies. All research carries with it an obligation to ensure optimal therapy for participating patients, providers and organizations and optimal conduct of the research such that the participation is meaningful. Accurate and timely knowledge of the progress of each study is a critical Research Base responsibility. The elements described below are considered essential for study monitoring:
Member Performance Evaluations
The Research Base is responsible for oversight of all its members (i.e., Community sites, Minority/Underserved Community Sites, and other member institutions) including placing members on probation for inadequate performance and for removing them from the Research Base if performance is not adequate during the probationary period or at any time during which the participating site does not meet established Research Base standards. Performance factors to be considered include the following:
Training Program
The Research Base should have training activities that address data collection, data management, and overall data quality, including but not limited to the following areas:
Central Review and Scientific Research Committees
Research Bases should either develop or utilize established Committees for conducting central review of the major elements that affect the outcome of cancer prevention and control studies or provide integral/integrated translational science associated with specific trials, including the following:
Research Bases should develop Committees for conducting central review of cancer care delivery research studies and interface with the Cancer Care Delivery Research Coordination Committee to, review infrastructure development of affiliated sites, determine study needs, and allocate resources. Cancer care delivery research Committees may include:
Onsite Auditing
The NCORP Research Base has responsibilities with respect to onsite auditing. In particular, the Research Base should ensure that policies and procedures are in place to ensure that auditors participating in the onsite auditing program maintain confidentiality of all participant materials.
Information on the requirements for onsite auditing is provided by Guidelines from the Clinical Trials Monitoring Branch (CTMB) of NCI/DCTD/CTEP available at:
http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm
In order for the NCI to review the Research Base s compliance with this requirement, each Research Base should provide annually an accounting of audit activities for all its members (see the Suggested Format for Reporting Onsite Auditing Activities at http://prevention.cancer.gov/ncorp
The Research Base is responsible for oversight of all its members enrolling patients on NCORP studies that any member credits to the Research Base regardless of whether the Research Base is leading the study or not. This includes ultimate oversight responsibility for Community and Minority-Underserved Community site members as well as affiliates when accrual for an enrollment in an NCORP trial is credited to the Research Base. The Research Base should be aware of all affiliate sites participating in its studies under the aegis of an institutional member, Community site, or Minority-Underserved Community site via its consolidated roster. Any members of a Research Base found not to be in compliance with the NCI Guidelines for Onsite Monitoring by the CTMB may be suspended from participating in any NCORP trials until a corrective action plan is submitted by the institution/site to the Research Base and is reviewed and approved by the Research Base and DCP.
Additional information on quality assurance required of Research Bases with respect to trial data and, in particular, procedures a Research Base is required to follow in the event any data irregularities are identified through the audit program or other quality control procedures are explained in detail in these Terms and Conditions of Award
With respect to cancer care delivery research, the audit requirements will be defined by the Cancer Care Delivery Research Coordination Committee.
Financial Management
The Research Base is responsible for its own financial management, including appropriate funding for all Research Base activities and provision of funding to member institutions/sites through purchase service agreements or subcontracts as well as funding for other important scientific and administrative services needed for Research Base functions such as support for Study Chairs and Scientific Research Committee Chairs.
Each Research Base’s clinical trials protocol approved by NCI for Community or Minority/Underserved Community Site and/or affiliate institution use will be assigned a credit value by NCI/DCP (credits do not apply to cancer care delivery research studies). The credit assignment will be detailed within the protocol approval letter. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. The credit is a one time credit claimed by Community or Minority/Underserved Community Site grantees' against the grant year in which the participant was enrolled on the protocol. A follow-up credit can be claimed one time per year for each year that there is an intervention (i.e., chemo-preventive agent and/or placebo administered) starting the year after the participant was enrolled.
Non-NCORP institutions will receive per case reimbursements for accruals to cancer prevention and control trials from the Research Bases.
The Research Base should ensure that funding is allocated at the site so that investigators and research staff from different departments and disciplines at the institution that participate in NCORP studies are appropriately represented in the disbursement of funding. For example, the Principal Investigator(s) at an institution/member site, with which a Research Base has a subcontract or purchase service agreement (PSA) for work related to enrollment of patients and conduct of studies in NCORP, may be a member of the Medical Oncology department at the institution, yet work under the subcontract or PSA which is performed across multiple departments at the institution (e.g., surgery, pathology, radiation oncology). The Research Base should strive to ensure that all member institutions/sites distribute funding to all departments involved in support of NCORP studies in a manner that reflects the work performed by the various members of the research team.
Any separate, non-NCI/DCP funding (i.e., funding not provided under the Cooperative Agreements of NCORP) dispensed by a Research Base to cover costs associated with participant enrollment on NCORP studies that it leads must be provided to all qualified institutions/sites that participate in its NCORP studies regardless of which Research Base the enrolling institution belongs to and/or applicable credits with the patient clinical trial accrual. This principle is considered an essential feature of NCORP and the Terms and Conditions of Award as it is fundamental to ensure fairness for work performed across the Network.
Program for Collaborations and Participation in Collective Management
NCORP Research Bases are responsible for developing collaborations with other Research Bases as well as other NCI-sponsored programs and investigators (e.g., Cancer Centers, R01/P01 investigators, NCI Cancer Research Network) to augment and enhance the clinical and cancer care delivery research strategy and research productivity of its portfolio of studies conducted in NCORP.
In addition, the Research Base is also responsible for participating in the collective management of the NCORP Network including participation in appropriate NCORP Program activities and initiatives (e.g., NCI Scientific Steering Committees, NCI CIRB, etc.) and through the NCORP Leadership Management Committee by making recommendations to NCI for modifications to the Program as well as to standard NCORP common tools and services. Finally, the NCORP Research Bases are expected to cooperate in any program evaluation processes that are conducted including interacting with NCI representatives in coordinating the evaluation.
NCORP Research Bases will participate in the NCORP Cancer Care Delivery Research Coordinating Committee which will be comprised of representatives from NCI, all Research Bases and select Community Sites.
Each Research Base is required to have policies to encourage other Research Bases to name co-principal investigators for studies that the Research Base leads (in areas that other Research Bases have scientific research goals and/or scientific research committees) in order to augment accrual and participation in NCORP trials and cancer care delivery research.
Compliance with Federal Regulations for Clinical Research & Resource Sharing Plans
The Research Base is responsible for assuring that the Research Base and its member sites are in compliance with all applicable federal regulations concerning the conduct of human subjects research. Policies and guidelines to be addressed include the following:
Office for Human Research Protection (OHRP) Assurances
The Research Base must assure that each member (this includes all affiliates or participating sites enrolling participants under any of the membership categories for the Research Base) has a current, approved Federal wide Assurance (FWA), on file with OHRP. Information on assurances is available on the OHRP website at: http://www.hhs.gov/ohrp/. In addition, federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.
IRB Review of NCORP Studies by Member Institutions/Sites
The Research Base must assure that each protocol for an NCORP trial that one of its member institutions/sites credits to the Research Base is reviewed and approved by the appropriate Institutional Review Board (IRB) of the Research Base member prior to patient entry via the Regulatory Support Services (RSS) of the CTSU, and assure that each protocol is reviewed annually by the IRB so long as the protocol is active (it is anticipated that the adult or pediatric NCI CIRB will be the IRB of record in most cases). The Research Base must ensure that each member site forwards its regulatory documents to RSS, otherwise the site will not be allowed to enroll patients on NCORP trials.
Assurance of Appropriate Informed Consent by Member Institutions/Sites
The Research Base must have procedures in place to ensure that each member institution/site is trained and understands the policies and procedures relevant to ensuring that participants are enrolled on studies with appropriate informed consent per NCI/NIH policy and federal regulations. The template for the NCI informed consent document must be used for all NCORP trials, with appropriate modifications as approved by NCI/DCP for specific trials during the protocol development and review process. Information on the NCI informed consent templates is available at: http://cancer.gov/clinicaltrials/patientsafety/simplification-of-informed-consent-docs/page3.
IRB Review of the Research Base
Institutional Review Board (IRB) review of the Research Base grant is required. The IRB should be able to review not only clinical trials but also care delivery research. The IRB should determine and document that the Research Base has sufficient mechanisms in place to ensure that (1) oversight of data management and analysis and that Data Safety and Monitoring systems are adequate, especially with respect to promoting the confidentiality of patient data, given the nature of the research involved; (2) sample protocols and informed consent documents are developed and distributed to each member institution/site participating in a study; (3) each member institution/site holds or is covered under an applicable OHRP-approved Federal wide Assurance (FWA); (4) each protocol is reviewed and approved by the IRB covering the member institution/site prior to the enrollment of participants; (5) any substantive modification by the institutional member/site of sample consent information related to risks or alternative procedures is appropriately justified; and (6) informed consent is obtained from each participant in compliance with DHHS regulations. Information on this requirement for IRB review can be obtained on the OHRP website at: http://www.hhs.gov/ohrp/.
Biospecimen Sharing Policy
The Research Base is required to follow the NCI/DCP policy regarding review of requests for use of banked biospecimens collected in association with NCORP trials that it leads by DCP’s Protocol Review Committee or an NCI/DCTD-approved NCTN Correlative Science Committee as described in Part 1 Section IV.C.3. Research Bases are also required to have a plan/policy in place to describe how information on its inventory of biospecimens will be made available to the public that is submitted to and approved by the NCORP Director and the Lead NCTN Program Director, Associate Director Cancer Diagnosis Program, and Program Director of the Tumor Banking Program for the Network Groups. This inventory should be consistent with standards established by the Network Tumor Banking Committee for the NCTN Program.
Research Bases having legacy prevention trials must have policies in place for review and approval for requests for use of specimens in research studies.
Research Bases should also have plans in place regarding the following types of resources, as appropriate for the clinical research it conducts: Sharing Model Organisms and Genome Wide Association Studies (GWAS).
Special Requests for Use of NCORP Infrastructure Services
The infrastructure of NCORP, including NCI/DCP and NCI/Division of Cancer Control and Population Sciences (DCCPS) supported contract services, can only be used for NCORP studies approved by NCI/DCP under this Cooperative Agreement. In special circumstances, a Research Base may request limited use of certain services (e.g., regulatory support services (RSS), the Oncology Patient Enrollment Network (OPEN) for a related research effort or study such as a banking protocol not associated with a specific NCORP clinical trial that is supported by charitable funds or a related oncology research study funded by another NIH-funded program). These requests must be reviewed and approved by NCI/DCP and NCI/DCCPS via an official written approval by the NCORP Director and NCORP Associate Director. In addition, any special request for use of NCORP infrastructure services for cancer care delivery research studies (e.g. studies sponsored through the Department of Veterans of Affairs) also must be approved by the NCORP Director and Associate Director. It is expected that only requests that are compatible with and are anticipated to benefit the overall research goals of NCORP would be approved, subject to the availability of NCORP resources/funding, since the use of the requested services are funded under NCORP.
Concept, Protocol, and Amendment Development, Review, and Approval: Cancer
Prevention and Control and Cancer Care Delivery Research Studies
A concept is submitted for review to the DCP Protocol Information Office (PD/PIO); All concepts for cancer prevention, control, and care delivery studies must be submitted to the NCI DCP Protocol Information Office (PD/PIO) at: http://prevention.cancer.gov/clinicaltrials/management.pio.
Concepts are reviewed by NCI/DCP/DCCPS staff as well as appropriate NCI Scientific Steering Committees.
If the concept is approved, a protocol document with an informed consent document is submitted for review to the DCP PD/PIO.
Investigational Agent Development and Regulations
The clinical development of new cancer preventive agents is an important use of Research Base resources. The Research Bases are a vital component of the research apparatus necessary for the clinical development of new investigational agents. NCI/DCP Program Directors (working as needed with other NCI program staff members) will advise investigators of specific requirements and changes in requirements concerning investigational drug management that the FDA may mandate.
NCI/DCP and NCI/DCTD staff will review general policies
and procedures periodically, as needed, and provide advice regarding mechanisms
established by the Research Bases to meet FDA regulatory requirements for
studies involving DCP-sponsored investigational agents.
Decisions on Study Proposals
The appeals process for decisions related to study proposals supported under NCORP (including both intervention and non-intervention studies) is described below.
For NCORP concepts evaluated by NCI Scientific Steering Committees or the DCP Concept Review Committee, or the DCCPS Concept Review Committee that are not approved for development based on scientific merit, the Research Base may appeal the decision to the Director, Division of Cancer Prevention, if the Research Base believes that there were factual errors in the evaluation that led to the disapproval. If the Director agrees with the appeal request by the Research Base, the Director will direct the appropriate NCI Steering Committee, DCP or DCCPS Concept Review Committee to re-evaluate the study proposal. The result of the re-evaluation will be considered final.
Any approval of a concept, even after appeal, is subject to feasibility/resource considerations as determined by NCI/DCP.
Development of Collaborative Trials and International Trials
A guidance document from NCI/DCTD/CTEP entitled, Cooperative Group Guidelines for the Development, Conduct and Analysis of Clinical Trials with International Collaborating Institutions, is available on the CTEP website at: http://ctep.cancer.gov/guidelines/nci_clin_intl_guidelines.pdf. This document addresses the various regulatory issues involved in the conduct of international trials that involve participation/leadership of Network Groups under the NCTN Program.
Legacy Studies
Legacy studies supported by the Community Clinical Oncology Program will be conducted under the same Terms and Conditions of Award as NCORP studies. Hence, the awardees of any of the key components of NCORP (i.e., NCORP Research Bases, NCORP Community Sites, and NCORP Minority-Underserved Community Sites) are bound by the Terms and Conditions of their Award under NCORP when working on legacy studies that are supported by NCORP
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NCI Program staff members acting as a Project Scientists/Coordinators will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement (e.g., in the role of Project Coordinators). The NCI Project Scientists/Coordinators will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.
Additionally, an NCI program director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Program Official is expected to act as the director of the NCORP program. Another NCI Program staff member will be named as Associate NCOPR Director, responsible for cancer care delivery research components of NCORP. These individuals may also have substantial programmatic involvement (as Project Scientists/Coordinators). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above.
The main NCI responsibilities are related to research efforts of the NCORP Program and include but are not limited to the following activities:
Details on the NCI roles in the key NCORP activities are provided below.
Research Priorities
NCI/DCP staff members will be responsible for maintaining a clear set of national priorities for cancer prevention, control and screening/post-treatment surveillance research, based upon substantial consultation with experts in the field. Additionally, NCI/DCCPS staff members will maintain a clear set of national priorities for cancer care delivery research, based upon substantial consultation with experts in the field. In selected topic areas, particularly when spontaneous planning does not occur within the Research Bases, DCP and DCCPS staff members (with support from the Coordinating Center for Clinical Trials [CCCT]) will help in coordinating the organization of Study Planning Meetings under the auspices of the NCI Scientific Steering Committees. In addition, DCP and DCCPS staff may support ad hoc scientific meetings to help achieve consensus on critical research problems. These Study Planning meetings and ad hoc meetings will be composed of investigators with established expertise in the particular field of interest and will consist primarily of extramural scientists and members of the SSCs. Priorities will be based upon the state of the science, NCORP Research Base resources, and availability of funds. NCI staff will be responsible for prompt dissemination of the recommendations from these meetings, particularly regarding statements of research priorities from Study Planning meetings, and the Research Bases will be encouraged to address these priorities.
Roles of NCI Staff Members as Scientific Resource for NCORP Research
The NCI staff members will assist NCORP Research Bases as appropriate, in developing information concerning the scientific basis for specific trials or alternative study designs, operational and regulatory issues, and will also be responsible for advising the Research Bases of the nature and results of relevant trials and other studies being carried out nationally or internationally. Where applicable, NCI staff members will also provide updated information to the Research Bases on the efficacy, toxicity, and availability of all Investigational New Drugs (IND) supplied by NCI to the Research Bases. In addition, NCI will advise the Research Bases of potential agents/interventions that will be relevant to new avenues of cancer prevention, control and screening/post-treatment surveillance. NCI will also share with NCORP updated information to compliment research initiatives and projects as part of other NCI research cancer care delivery projects that may be relevant to NCORP research priorities and concept development.
Concept Review
NCI program staff reviews each submitted concept to determine that the proposed research is relevant to cancer prevention, control, and/or care delivery and that the concept includes all required components. NCI program staff will return to Research Bases concepts that do not fulfill these criteria together with a letter that explains the reasons for not accepting the concept for review.
The DCP CRC or DCCPS CRC evaluates all NCORP concepts for the scientific rationale, programmatic relevance; potential impact on cancer prevention, control and care delivery; priority; design; statistical requirements; plans for conducting the proposed study; the feasibility and appropriateness of the research for use by NCORP Community Sites or in a community setting; the existence and nature of concurrent clinical trials/studies in the area of research, including research in other NCI-funded programs that may compete with or complement the proposed study; and, where applicable, the availability of investigational agents.
Protocol Review
DCP/COPTRG will assist the Research Bases in clinical trial design to develop a mutually acceptable protocol compatible with the research interests, capabilities, and needs of the Research Base, its affiliates, and NCI. The protocol review will focus on the inclusion in the protocol of all information and procedures necessary for conducting a successful study. Specific attention is paid to responses to concerns of the SSC and/or DCP/DCCPS conveyed to the Research Base at the time of concept approval. Since the rationale for the study and the broad study design have already received, these are not generally the focus of a protocol review. However, if the protocol differs from the concept in significant ways (e.g. change in endpoint, change in participant eligibility criteria), the Protocol Review Committee will review all aspects of the protocol to determine that the study has scientific validity and is feasible to conduct in NCORP network.
Data and Safety Monitoring Boards (Data Monitoring Committees)
The NCORP Director will designate Program Directors to serve as cancer prevention and control liaisons on Data and Safety Monitoring Boards (DSMBs), also known as Data Monitoring Committees (DMCs), for NCORP phase 3 trials as well as phase 2/3 and any other phase 2 trials monitored by the DSMB/DMC. One or more DCP/COPTRG staff will serve as non-voting members at each Research Base DSMB/DMC meeting. NCI/DCP Program Directors will review Research Base mechanisms for interim monitoring of results, will monitor clinical trial progress, and will assess Research Base compliance with NCI-established policies on Data and Safety Monitoring Plans for Phase I and II trials and Data and Safety Monitoring Committees for Phase III trials.
Because NCI/DCP staff serve as non-voting members of the Research Base DSMBs/DMCs, to ensure compliance with NIH/NCI policies and protocol requirements, NCI/DCP staff members recuse themselves from NCI/DCP review of substantive protocol amendments (e.g., amendments for increases in sample size or significant changes in trial design) for any study that is also under review by a DSMB/DMC of which they are members, if confidential outcome data on that study have been previously presented to the DSMB/DMC. When this situation arises, the amendment is reviewed by NCI/DCP staff members who are not members of that DSMB/DMC.
Additional NCI Scientific Support to NCORP Awardees
Each NCORP Research Base, Community Site, and Minority/Underserved Community Site will also have a program staff member(s) from DCP/COPTRG assigned to them who will act as liaisons for scientific matters related to clinical trials and clinical research studies.
The NCI will also assign to each NCORP awardee a program staff member(s) from DCCPS who will have clinical, health services and behavioral research expertise to act as liaisons for scientific matters related to cancer care delivery research studies.
The NCI will have access to all data (including imaging data) collected and/or generated under this Cooperative Agreement and may periodically review the data. The NCI may also review all records related to awardees performance under the award for appropriate collection, review, and distribution of biospecimens collected in association with NCORP clinical trials.
The NCI reserves the right to reduce award budget, withhold support, suspend, or terminate the award in cases of insufficient patient accrual per the protocol specified timelines and/or NCI/DCP slowly accruing guidelines for clinical trials, inability to meet the scientific aims of the Cooperative Agreement, or noncompliance with the Terms and Conditions of Award.
Areas of Joint Responsibility include:
NCI Program staff members and the NCORP awardees will collaborate on general aspects of study development and conduct. Areas for such collaborations are particularly expected to include various administrative and regulatory aspects such as:
Collective Management of NCORP
In order to provide for collaboration and coordination of policies and procedures for NCORP, collective management is needed. To achieve this goal, a core collective management team (i.e., NCORP Leadership Management Committee) composed of 1 senior leadership representative from each of NCORP Research Bases and key NCI program leadership from relevant Divisions and Centers to discuss major policy issues and address concerns about NCORP. The Committee will make recommendations to senior NCI leadership on the Program. It is anticipated that the Committee will meet on at least a quarterly basis by teleconference and/or in-person. Additional representatives from NCORP may be invited to participate in meetings depending on the issues to be discussed. It is also anticipated that there may be meetings held specific to NCORP Directors of Operations/Group Administrators on a periodic basis to discuss significant issues, as appropriate.
Specific areas that will require recommendations from NCORP Leadership Management Committee include but are not limited to the following:
NCORP Cancer Care Delivery Research Coordination Committee. NCORP will have a designated Committee to coordinate efforts in cancer care delivery research. The Committee will be convened jointly by the NCI and NCORP Research Base awardees. Initially, the committee will consist of the following members:
These initial members of the Committee will decide on its final composition, structure, procedures, etc. Community Sites and Minority/Underserved Community Sites will represented on an ad hoc basis. Additional representatives of Research Bases and NCI as well as external experts may also be involved in the activities of the Committee, e.g. as ad hoc members.
The Committee will have access to NCORP-wide repository information from NCORP Community Sites and Minority/Underserved Community Sites (e.g., cancer registry data, processes of care data and data on organizational characteristics and policies).
The specific functions of the Committee are expected to include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Network Group representatives on the NCORP Leadership Management Committee chosen by them without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual awardee. The appeals process and this special dispute resolution procedure do not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons registration,
submitting and tracking an application, documenting system problems that
threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
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process, finding NIH grant resources)
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TTY: 301-451-5936
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Worta McCaskill-Stevens, M.D., M.S.
National Cancer Institute (NCI)
Telephone: 240-276-7050
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: (240) 276-6390
Email: [email protected]
Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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