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National Institutes of Health (NIH)
National Cancer Institute (NCI)
Funding Opportunity Title
NCI National Clinical Trials Network - Network Group Statistics and Data Management Centers (U10)
U10 Cooperative Clinical Research – Cooperative Agreements
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Only one application from an eligible institution is allowed as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
This funding opportunity announcement (FOA) solicits applications from institutions/organizations to establish Network Group Statistics and Data Management Centers Centers for the NCI National Clinical Trials Network (NCTN). The goal of the NCTN is to develop and conduct state-of-the-art cancer treatment and advanced imaging clinical trials, especially large, definitive multi-institutional trials evaluating new cancer therapies and related clinical approaches for both adult and pediatric patients. The NCTN consists of six components each with its own FOA, which are: Network Group Operations Centers; Network Group Statistics and Data Management Centers (covered by this FOA); Network Group Integrated Translational Science Centers; Lead Academic Participating Site Centers; Network Radiotherapy and Imaging Core Services Centers; and a Canadian Collaborating Clinical Trials Network.
The NCTN Network Group Statistics and Data Management Centers will provide statistical expertise for effective scientific design and conduct of clinical trials as well as data management for NCTN trials led by the associated Network Group Operations Centers.
July 23, 2012
Letter of Intent Due Date
December 15, 2012
Application Due Date(s)
January 15, 2013
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date(s)
March 1, 2014
January 16, 2013
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the PHS398 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.
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 six FOAs that reflect the comprehensive effort by the National Cancer Institute (NCI) to transform the previous NCI-sponsored Clinical Trials Cooperative Group Program from supporting several individually operating Cooperative Groups into a new consolidated and integrated NCI National Clinical Trials Network (NCTN) Program. The overall goal for the entire NCTN Program is to conduct definitive, randomized, late phase clinical treatment trials and advanced imaging trials across a broad range of diseases and diverse patient populations as part of the NCI’s overall clinical research program for adults and children with cancer. The NCTN will also conduct, as necessary, smaller developmental studies preliminary to the definitive trials. The NCTN Program will be based on an integrated network of clinical trials groups that will collaborate with each other as well as with other NCTN components and other NCI-sponsored programs and investigators.
The NCTN Program will support the following components that will be individually awarded through the respective FOAs indicated below:
1) Network Group Operations Centers under RFA-CA-12-010 (U10) (up to 5 awards);
2) Network Group Statistics & Data Management Centers under RFA-CA-12-011 (U10) (this FOA, up to 5 awards);
3) Network Group Integrated Translational Science Centers under RFA-CA-12-012 (U10) (5-7 awards);
4) Network Lead Academic Participating Sites under RFA-CA-12-013 (U10) (30-40 awards);
5) Network Radiotherapy & Imaging Core Services Centers under RFA-CA-12-014 (U24) (up to 1 award); and
6) Canadian Collaborating Clinical Trials Network RFA-CA-12-504 (Limited Competition U10) (up to 1 award).
The new consolidated structure of the NCTN is designed to comprise five U.S. Network Groups (up to 1 pediatric group and up to 4 adult groups) and up to 1 Canadian Network Organization. Each U.S. Network Group will be organized around a dedicated Operations Center working with an affiliated Statistics and Data Management Center and other NCTN components as appropriate.
Note: An overview of the roles of individual NCTN components is outlined below. However, it is imperative that prospective applicants read the individual FOAs for those components for which they intent to apply.
This FOA provides expanded information specific to Network Group Statistics and Data Management Centers and details needed to apply for a Network Group Statistics and Data Management Center award.
For more than 50 years, the NCI has supported a standing clinical trials infrastructure – the NCI National Clinical Trials Cooperative Group Program (also referred to as the "Group Program") – funded through the Division of Cancer Treatment and Diagnosis (DCTD) to conduct large-scale, clinical treatment trials across the nation. The Group Program has successfully completed many important trials that have led to new treatments for cancer patients. Its activities have involved more than 3,100 institutions and 14,000 investigators enrolling between 20,000 to 25,000 patients in clinical treatment and advanced imaging trials each year over the past decade. The Group Program has promoted the evaluation of multi-modality treatments and combinations of novel agents. In addition, studies supported by Group Program have emphasized clinical trials in members of special populations (e.g., children, young adults, and underserved populations) and clinical trials focused on rare tumor types. This focus has allowed the Group Program to complement, rather than duplicate, research supported by the private sector.
Cancer medicine has evolved in recent years into a more molecularly-based discipline. Diagnosis is being improved through genetic sub-classification as well as functional imaging of tumors and new treatments are being developed aimed at specific cancer-related pathways. As part of its effort to take advantage of new discoveries in oncologic science, NCI asked the Institute of Medicine (IOM) in 2009 to review the NCI-sponsored Clinical Trials Cooperative Group Program. The IOM report (http://iom.edu/Reports/2010/A-National-Cancer-Clinical-Trials-System-for-the-21st-Century-Reinvigorating-the-NCI-Cooperative.aspx) noted that, despite its impressive record of accomplishment, the current trials system has become less efficient, has difficulty prioritizing studies, and has been underfunded for the number of trials that it conducts. The IOM report recommended that the existing adult Clinical Trials Cooperative Groups be consolidated into a smaller number of Groups, each with greater capabilities and appropriate incentives to promote better overall system integration. Consolidation should promote efficiency by encouraging a structural makeover of clinical trial group operations centers and statistics and data management centers. It should also facilitate prioritization in clinical research by focusing trials even more than before on questions unlikely to be addressed by the private sector.
Based on the IOM review recommendations as well as additional input received by the NCI from stakeholders across the oncology community, the NCI has developed a comprehensive plan to transform the previous NCI-sponsored Clinical Trials Cooperative Group Program that funded several separate organizations conducting cancer treatment trials into a new consolidated and integrated Program referred to as the NCI National Clinical Trials Network (NCTN).
The overall goal of the NCTN Program is to conduct definitive, randomized, late phase clinical treatment trials and advanced imaging trials across a broad range of diseases and diverse patient populations, as well as development efforts preliminary to those trials, as part of the NCI’s overall clinical research program for adults and children with cancer.
In order to achieve the overall goal of the Program, essential features of the NCTN will include:
In the NCTN Program, a Network Group is defined as a clinical trials group with a dedicated Operations Center and an associated Statistics and Data Management Center responsible for the design and development of clinical trials as well as the conduct of trials via member institutions/sites that enroll patients. Member sites of Network Groups include institutions/sites that are funded either directly by the Network Group Operations Center for their participation in NCTN trials or through other funded key components of the NCTN (i.e., Lead Academic Participating Sites award) or through related NCI-sponsored programs that fund participation (i.e., Community Clinical Oncology Program, Minority-based Community Clinical Oncology Program). Network Groups are expected to collaborate with each other and with NCI to achieve the overall goal of the Program. Member institutions/sites of Network Groups will be able to enroll patients on all adult Phase 3 trials as well as select early phase trials, irrespective of the specific Network Group that is leading the trial. In addition, select trials for adolescent and young adults will be open to all member institutions/sites. Network Groups will also provide trial operations, data management, and statistical support for approved, multi-center Phase 2 and Phase 3 trials originating outside the Network.
Each Network Group will have an integrated organizational structure encompassing scientific leadership, statistics, clinical trial operations, data management, and administration. Network Groups will be funded through an Operations Center award (covering scientific leadership, trial operations, and general administration including oversight of member institutions/sites enrolling patients) and a separate Statistics and Data Management Center award (covering statistical design and data management). Organizations may also apply for a separate, integrated, translational science support center award with support from one or more Network Groups - i.e., Operations Center(s) and associated Statistics and Data Management Center(s) – to facilitate integration of translational science into the design of clinical trials conducted by the supporting Network Group(s).
In addition to the awards described above, the NCTN Program will involve several awards to Lead Academic Participating Sites or institutions to support scientific leaders at those sites who are affiliated with one or more Network Groups to provide leadership in the design and conduct of trials as well as to support patient enrollments at their sites to NCTN trials. The Program will also support an award for an organization to provide core services related to incorporating appropriate quality assurance and credentialing of radiotherapy and imaging techniques/approaches in clinical trials to all the Network Groups and an award to sponsor a corresponding Canadian clinical trials organization to partner with the Network Groups in the U.S. in the design and conduct of NCTN trials.
Each of these key components of the NCTN Program is described briefly below.
Interactions with Other NCI-supported Programs. In addition to the six key components of the NCTN that are described above and will be directly funded by the NCTN Program, other NCI grant and contract supported Programs and their awardees as well as NCI Advisory Committees will have important supporting roles in carrying out the research objectives of the NCTN Program. Thus, the NCTN awardees will be expected to interact as appropriate with such entities/programs as the NCI Clinical Trials Tumor Banks, the Community Clinical Oncology Program (CCOP) and Minority-Based Community Clinical Oncology Program (MB-CCOP), the NCI Cancer Trials Support Unit, the pediatric and adult NCI Central Institutional Review Boards, and NCI Advisory and Scientific Committees including the NCI Scientific Steering Committees.
The Network Group Statistics and Data Management Center application must address the following 2 required functional components:
PROGRAM EVALUATION: The NCTN program will be subject to external evaluation near the end of the funding period (to be coordinated by the NCI Program Staff). Such evaluation is part of NIH efforts to optimize the efficiency of the funded research. The evaluation process will involve monitoring and assessing the progress of the NCTN toward achieving its goals. This aspect includes evaluating the quality, value, and scientific impact of the clinical trials and other research activities conducted by the NCTN, timeliness of clinical trial development and completion, efficiency of operations, effort integration and collaborations across the Network, and interactions with other relevant NCI-sponsored organizations and programs. For the efficient evaluation of the NCTN Program, cooperation of all the NCTN awardees (for all types of the NCTN components) will be important and expected.
Application Types Allowed
The OER Glossary and the PHS398 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 $35 million for up to 5 awards (up to 1 pediatric and up to 4 adult Network Group Statistics and Data Management Centers) in FY 2014. Future amounts will depend on annual appropriations.
Application budgets are not limited, but need to reflect 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 will vary.
Award Project Period
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
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 allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.
With the restrictions defined below, 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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
An individual who is designated as a PD/PI on the application for a Network Group Statistics and Data Management Center MUST NOT be listed as a PD/PI on an application for any of the NCTN key components listed below:
However, an individual who is designated as a PD/PI on the application for a Network Group Statistics and Data Management Center can, if appropriate, be listed as key personnel in the application for its associated Network Group Operations Center and/or the application for the Network Radiotherapy and Imaging Core Services Centers (RFA-CA-12-014), but not on the other applications listed above and not on the applications for other Network Group Operations Centers.
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. An organization applying for the Network Group Operations Center award under RFA-CA-12-010 cannot apply for a Network Group Statistics and Data Management award under this FOA.
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 PHS398 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:
Meg Mooney, MD
Clinical Investigations Branch, Cancer Therapy Evaluation Program
National Cancer Institute
6130 Executive Boulevard, Room 7024, MSC 7340
Bethesda, MD 20892-7340 (for U.S. Postal Service regular or Express Mail)
Rockville, MD 20852 (for non-USPS delivery)
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:
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements: Section 3 - Research Strategy of the PHS 398 Research Plan must consist of the new sub-sections A-C with the following individual page limits as noted below.
A. Statistics and Data Management Center Overview - 12 pages
B. Statistical Analysis Program & Collaborative Research and Collective Management - 30 pages
C. Data Management Program– 30 pages
In addition to standard information, provide in this section documentation of important capabilities and available resources as indicated for specific functional components of the Network Group Statistics and Data Management Centers below. Relevant information may be provided in tabular form as listed below. Applicants are strongly encouraged to use, as appropriate, table templates provided in Part 4 - Appendices - Section II.B. of the Guidelines document for the NCTN Program (http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies).
Table 1. Key Leadership Staffing
Table 2. Summary of General Data Timeliness
Table 3. Summary of Data Quality and Data Timeliness – Serious AE Reporting
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
This sections must consist of the subsections A-C described below. For full details on the content and organization of the individual sub-sections please see the Guidelines document for the NCTN Program (http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies) in Part 2 - Section II.C.2.
Sub-Section A. Statistics and Data Management Center Overview (up to 12 pages)
This section should provide a general overview of the Statistics and Data Management Center
(SDMC) and describe the general features and operations of the SDMC. The applicant should provide a diagram illustrating the organizational structure of the SDMC in this section, particularly the relationship between the Statistical Analysis Program and the Data Management Program and describe how the SDMC would interact with the other key components of the NCTN Program.
Sub-Section B. Statistical Analysis Program & Collaborative Research and Collective Management (up to 30 pages)
Statistical Analysis Program: This functional component should consist of a well-defined organization, approaches, policies, and procedures for statistical analysis of clinical trials in specific disease areas and patient populations. The applicant should describe the organizational structure, governance, and standard operating procedures in order to demonstrate the applicant's capability to design, monitor, and analyze clinical trials in a timely manner. The expertise and experience as well as the scope and authority of the applicant's statistical leadership team, including how the team directs the Data Management Program and how the team interacts with the Director of Operations position for the associated Network Group Operations Center should be described, including succession planning for key leadership positions in the statistical program.
For applications designating multiple PD(s)/PI(s), a leadership plan related to the multiple PD/PI designation must be included in the appropriate section of the application (i.e., Multiple Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)) Leadership Plan section of the PHS 398). A rationale for choosing a multiple PD(s)/PI(s) approach should be described. The governance and organizational structure of the leadership team for the SDMC should be described including communication plans, process for making decisions and procedures for resolving conflicts. The roles and administrative, technical, and statistical responsibilities for the SDMC should be delineated for the PD(s)/PI(s), including responsibilities for protection of information on human subjects in clinical studies. If budget allocation is planned, the distribution of resources to specific components of the SDMC and/or the individual PD(s)/PI(s) should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote of the Notice of Award.
The applicant should describe the general approach to statistical trial design and analysis plans for multi-institutional clinical trials, including guidelines for interim monitoring and general procedures for sample size estimation and choice of testing and estimation procedures. Examples of robust statistical trial designs and statistical support should be described as well as how the SDMC provides statistical leadership in design and analysis, including incorporating new, integral and integrated, molecular and imaging biomarkers and laboratory studies into the overall evaluation of NCTN trials. The applicant should also describe how the SDMC ensures that final study analyses are performed in a manner to provide timely publication of study results and results reporting per NCI and federal regulations.
Collaborative Research: The applicant should highlight its current collaborations and future plans for collaborations/initiatives with other clinical trials organization on the statistical design and analysis of clinical trials as well as with other NCI-sponsored programs and investigators on ancillary studies (e.g., translational research, laboratory studies) associated with clinical trials as an indication of the applicant's potential to be a collaborative partner in the NCTN Program. In particular, the applicant should describe the capability of the SDMC to provide statistical design and analysis for non-Network Group trials. While independent statistical research is not required (or funded under this FOA), involvement in research related to the design, conduct, and analysis of cancer clinical trials is considered a strength, and the applicant should therefore describe research being conducted by the SDMC statisticians using Network Group SDMC and Operations Center resources, including their clinical databases.
Collective Management: The applicant should address how it can contribute to the collective management of the NCTN Program through examples of participation in the NCI Scientific Steering Committees (SSC) and associated Task Forces and Working Groups, Planning Committees for SSC Clinical Trials Planning, and NCI CIRB or examples of similar activities in other clinical trial networks as indications of its potential to participate in the collective management of the NCTN. The applicant should also describe how it coordinates with the Tumor Bank(s) associated clinical trials organization to ensure that clinical data is provided in a timely and user-friendly format for public access to data from clinical trials and for studies approved for use of biospecimens as an indication of the applicant’s potential to provide these services efficiently for the NCTN Program. In addition, the applicant should describe its track record in and potential to implement initiatives and new standards for clinical trial conduct and data management in a timely fashion.
NOTE: Information on the applicant’s statistical leadership in clinical trial design and analysis as well as achievements of its past record (over the prior 5 to 6 years) and current plans may be summarized in the sections above.
Sub-Section C. Data Management Program (up to 30 pages)
This functional component should consist of a well-defined plan for data management of NCTN trials, both trials led by the applicant's associated Network Group Operations Center including approved multi-center Phase 2 and Phase 3 trials that originate from outside the associated Network Group Operations Center.
The applicant should provide a detailed description of the data management and study monitoring practices of the SDMC, including the flow and review of data following submission from individual institutions/sites and investigators. The applicant should describe the data management systems employed and how the SDMC would use standard NCTN tools including the NCTN Common Data Management System (CDMS) and use of NCTN-approved Common Data Element (CDEs) from the Cancer Data Standards Registry and Repository (ca-DSR), the NCTN Regulatory Support System (RSS), the NCTN Oncology Patient Enrollment Network (OPEN), the NCI/DCTD Clinical Data Update Systems (CDUS/CDS), the NCI Expedited Adverse Event Reporting System (AdEERs), the NCI Common Terminology Criteria for Adverse Events (CTCAE) for data management for NCTN trials, and trial registration in the NCI National Clinical Trials Reporting Program (CTRP) and in the U.S. National Library of Medicine (NLM) (www.clinicaltrials.gov) along with results reporting, as applicable. The applicant should describe how it coordinates with the associated Network Group Operations Center to ensure that data and biospecimens can be made available to the public for future research.
Descriptions of SDMC training for investigators, Clinical Research Associates, and study chairs related to data management and study monitoring for clinical trials should be provided. The applicant should also describe procedures for study monitoring as well as for data quality control and accuracy verification, including how the SDMC works with the associated Network Group Operations Center on auditing activities. The applicant's method for active trial monitoring, including procedures for accrual and biospecimen collection tracking, assessing case, eligibility and evaluability, ensuring timely medical review and assessment of patient data, monitoring of data timeliness, and facilitating SDMC staff interactions with study chairs should be described. The applicant should describe the SDMC's guidelines for institutions/sites for data timelines, including a summary of data quality and timeliness as an indication of its potential to operate efficiently within the NCTN Program.
The applicant should also describe the facilities and equipment available as well as the information technology (IT) support for central storage, security, analysis and retrieval of clinical data. The applicant should describe how it complies with the Constitution & By-laws of the associated Network Group Operations Center as well as its conflict of interest policy and guidelines for good clinical practice. The applicant should describe how it complies with federal/DHHS/NIH/NCI regulations for clinical research involving human subjects as well as with NCI/NIH administrative requirements for conduct of clinical trials with respect to NCI/DCTD's IP Option and NCI/DCTD's collaborative binding agreements for NCI/DCTD IND studies.
NOTE: Appropriate summary documentation of the track record of the applicant team with respect to key statistical leadership staffing and timely data management and data collection for clinical trials over the past 5 to 6 years may be presented in summary tables to be included under "Resources", as indicated above. In addition, the applicant's key standard operating procedures for the conduct of clinical trials related to the following may also be provided in the Resource section of the application:
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 PHS398 Application Guide with the following modifications:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 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 PHS398
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
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be received 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. Applications that are incomplete and/or nonresponsive will not be reviewed.
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration Information."NOTE: The applicant should review the Cooperative Agreement Terms and Conditions of Award prior to preparing the application as these terms include information and clarifications needed by the applicant to understanding the complete requirements of a Network Group Statistics and Data Management Center award.
Information on the targeted/planned enrollment for minorities and members of both genders as well as 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 Information on the targeted/planned enrollment for minorities and members of both genders as well as 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.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115. Note: Because applications submitted in response to this FOA have only one due date, applicants may submit materials per the exceptions list provided in NOT-OD-10-115 using the specified page limits.
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
For this particular announcement, the emphasis is on the capabilities and experience of the applicant team in successfully providing statistical analysis plans and data management and monitoring plans for large scale definitive clinical trials. As all applications submitted in response to this FOA will be “new” applications, those aspects will be largely evaluated based on the prior performance and productivity of the applicants. These capabilities and commensurate performance/productivity must be appropriate and consistent with specific requirements stated in this FOA. The required capabilities and experience are expected to reflect the properly documented successful performance of the applicant team under the former NCI National Clinical Trials Cooperative Group Program or equivalent large-scale NIH or other non-profit clinical trials networks or programs. Reviewers will be using this information as benchmarks in evaluating all aspects of the application, including plans for the specific components of the proposed Network Group Statistics and Data Management Center and its overall potential.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed Network Group Statistics and Data Management Center 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 proposed Network Group Statistics and Data Management Center 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 proposed Network Group Statistics and Data Management Center that by its nature is not innovative may be essential to advance a field.
Does the proposed Network Group Statistics and Data Management Center help address an important problem or a critical barrier to progress in the field? If the aims of the proposed Network Group Statistics and Data Management Center 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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the proposed Network Group Statistics and Data Management Center's Statistics Program and Data Management Program as well as its plans for collaborations and collective management? 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)? Given that all NCTN Program research projects/clinical trials are collaborative and regardles of whether the applicants choose to use the the multi-PD/PI option, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the clinical research that the proposed Network Group Statistics and Data Management Center helps conducts and manage?
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?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the proposed Network
Group Statistics and Data Management Center? 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?
Since the proposed Network Group Statistics and Data Management Center will help conduct clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of statistical analysis plans for minorities and members of both sexes/genders, as well as the inclusion of children, if applicable, justified in terms of the scientific goals and research strategy proposed?
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 clinical research analyzed and the clinical data managed by the proposed Network Group Statistics and Data Management Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Scored Review Criteria
In addition to the above review criteria, the following additional Criteria A-B will be applied in the determination of scientific merit and the impact/priority score:
A. Statistical Analysis Program & Collaborative Research and Collective Management and
B. Data Management Program
Reviewers will consider each of the additional review criteria below in the determination of scientific merit, and give a separate score for each.
(Note: The entire Criterion A will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately).
Statistical Analysis Program: How complete and comprehensive is the expertise of the applicant's investigators overall and the Senior Leadership of the applicant's proposed Network Group Statistics and Data Management Center? How well can the PD(s)/PI(s) and the entire team of investigators assembled by the applicant provide statistical leadership for state-of-the-art early and late phase clinical trials in adults and/or adolescents and young adults and children with cancer? Do the research experience and qualifications of the leadership team demonstrate understanding of design and analysis of multi-institutional clinical trials and relevant laboratory studies? Will these investigators be able to work as a cohesive research team to efficiently and expeditiously develop the statistical analysis plans for NCTN clinical trials as well as analyze results from completed trials? Does the Network Group Statistics and Data Management Center have a well-defined organizational structure and clearly defined roles and responsibilities for its staff? Does the applicant have appropriate and clearly defined succession and transition plans for the senior leadership of the proposed Network Group Statistics and Data Management Center?
If the application includes multiple PD(s)/PI(s), are the proposed leadership governance, organizational structure, and decision-making processes and interactions among the members of the leadership team for the application optimal for providing statistical expertise for effective scientific design and conduct of multi-disciplinary, multi-institutional trials in a range of cancer types and special populations with specific scientific strategy and goals?
How well has the proposed Network Group Statistical and Data Management Center (SDMC) demonstrated its ability and track record to provide appropriately designed, robust, statistical analysis plans for early phase and especially late phase, definitive, multi-institutional clinical trials in oncology, including integral and integrated biomarker/correlative science studies? Does it appear that the applicant has the necessary expertise and experience to incorporate new molecular and imaging biomarkers into the overall evaluation of NCTN trials appropriately? Are the procedures for sample size estimation, end point selection and monitoring plans adequately described and justified? Are analytical techniques, procedures, and policies adequate, appropriate, and consistent with accepted standards? Is there evidence that past publications by the SDMC demonstrate thorough and state-of-the-art methodology, awareness of problems of multiple analyses, and sufficient independence and lack of bias of statistical collaborators? Does the sample of trial reports from the Report of Studies indicate appropriate and timely data and study analyses?
Collaborative Research: Does the applicant have a track record for collaborations with other clinical trial organizations and other NCI-sponsored programs and investigators (e.g., SPOREs, NCI Cancer Centers, R01/P01 investigators) on statistical design and analysis on clinical trials and translational science studies that demonstrates its potential for collaboration within the NCTN Program? Has the applicant demonstrated that it has the capacity to provide statistical design and analysis (as well as data management) for clinical trials that come from investigators outside its associated Network Group Operations Center? Does the applicant demonstrate the ability to perform independent statistical research?
Collective Management Activities: Does the applicant have a track record that demonstrates that the members of its scientific and technical staff can participate in or can actively contribute to NCI clinical trial activities (e.g., disease-specific and modality-specific Scientific Steering Committees and related task forces or working Groups, Clinical Trials Planning Committees for meetings supported by the NCI disease-specific Steering Committees, participation in other NCI programs and initiatives related to clinical research)? Do SDMC members demonstrate the potential to participate as members of the NCI Central IRBs? Does the applicant have a robust plan to ensure that clinical data is provided in a timely and user-friendly format for public access to data from clinical trials and for studies approved for use of biospecimens and data as an indication of the applicant’s potential to provide these services efficiently for the NCTN Program? How well does the applicant demonstrate its potential to implement new initiatives and new standards for clinical trial conduct and data management in a timely fashion?
(Note: The entire Criterion B will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately).
Does the applicant describe well defined policies and procedures for data management of NCTN trials led by the applicant's associated Network Group Operations Center (including approved, multi-center phase 2 and phase 3 trials that originated from investigators outside the Network Group Operations Center)?
How appropriate and robust are the data management and study monitoring practices of the proposed SDMC, including the flow and review of data following submission from individual institutions/sites and investigators? How appropriate is SDMC training for investigators, Clinical Research Associates, and study chairs related to data management and study monitoring for clinical trials? How well do the data management systems employed by the proposed SDMC use standard NCTN tools including the NCTN Common Data Management System (CDMS) and use of NCTN-approved Common Data Element (CDEs) from the ca-DSR, the NCTN Regulatory Support System (RSS), the NCTN Oncology Patient Enrollment Network (OPEN), the NCI/DCTD Clinical Data Update Systems (CDUS/CDS), the NCI Expedited Adverse Event Reporting System (AdEERs), the NCI Common Terminology Criteria for Adverse Events (CTCAE) for data management for NCTN trials, and trial registration in the NCI Clinical Trials Reporting Program (CTRP) and in the U.S. National Library of Medicine (NLM) (www.clinicaltrials.gov) along with results reporting, as applicable? How able is the applicant to coordinate with the associated Network Group Operations Center to ensure that data and biospecimens can be made available to the public for future research?
How robust are the applicant's policies and procedures for study monitoring as well as for data quality control and accuracy verification, including how the proposed SDMC would work with its associated Network Group Operations Center on auditing activities as well as other quality assurance programs? How comprehensive and appropriate are the applicant's methods for active trial monitoring, including procedures for accrual and biospecimen collection tracking, assessing case, eligibility and evaluability, ensuring timely medical review and assessment of patient data, monitoring of data timeliness, and facilitating SDMC staff interactions with study chairs? Does the proposed SDMC have appropriate procedures in place to ensure compliance with federal/DHHS/NIH/NCI regulations for clinical research involving human subjects as well as with NCI/NIH administrative requirements for conduct of clinical trials with respect to NCI/DCTD's IP Option and NCI/DCTD's collaborative binding agreements for NCI/DCTD IND studies? Does the SMDC have clear guidelines for institutions/sites related to data timeliness and metrics for data quality for the clinical trial data and timely reporting to the institutions/sites of this information that indicate its potential to operative efficiently within the NCTN Program? Do the facilities and equipment (including computer hardware and software) available as well as the information technology (IT) support for central storage, security, analysis and retrieval of clinical data for the proposed SDMC appear adequate for clinical trial research? Does the proposed SDMC have policies and procedures in place that are in compliance with federal regulations related to confidentiality of patient data, including Health Insurance Portability and Accountability Act (HIPAA) regulations?
As applicable for the clinical research that the Network Group Statistics and Data Management Center has proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
Since the proposed Network Group Statistics and Data Management Center will t involve 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 Human Subjects Protection and Inclusion Guidelines.
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.
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.
As applicable for the Network Statistics and Data Management Center the applicant has 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/priority score.
Applications from Foreign Organizations
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 NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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 in response to this FOA.
Applications will be assigned to the NCI 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(s)/PI(s) 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
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, CCR 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.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NCI Program staff member(s) acting as a Project Scientist(s) 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 Scientist(s)/Coordinator(s) 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. Some Program Officials 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 Network and include but are not limited to the following activities:
The programmatic responsibilities for the NIH staff are completely described in NCI National Clinical Trials Network (NCTN) Program Guidelines available at http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies with the "NCI/DCTD Responsibilities" described in detail in Part 1 - Section IV.C. of the Guidelines document.
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 NCTN trials.
In case of insufficient patient accrual per the protocol specified timelines and/or NCI/DCTD slowly accruing guidelines for trials, inability to meet the scientific aims of the Cooperative Agreement, or noncompliance with the Terms and Conditions of Award, the NCI reserves the right to reduce award budget, withhold support, suspend or terminate the award.
Areas of Joint Responsibility include:
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, except for areas of dispute that are already addressed by the appeal process within the Terms and Conditions of Award for decisions regarding approval of NCTN study proposals and the types of studies supported by the NCTN Program as described in detail under "Appeals Process for Decisions Regarding Study Proposals & Types of Studies Performed by NCTN Program" in Part 1 – Section IV.E. of the NCI National Clinical Trials Network (NCTN) Program Guidelines.
For other scientific and programmatic matters that are not covered by the appeals process, 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 NCTN 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 DHHS 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) annually and financial statements as required in the NIH Grants Policy Statement. Additional required reporting by the Network Group Statistics and Data Management Center awardees is decribed in detail in the section on the Specific Awardee Rights and Responsibilities of the Network Group Statistics and Data Management Center under the Terms and Conditionsl of Award in the Guidelines document for the NCTN Program in Part 1-Section IV.B.2.
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.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
General Research Programmatic Information and Administrative Information:
Meg Mooney, MD
National Cancer Institute
Information on Scientific Program - Adult US Network Group Statistics/Data Mgt Center Applicants:
Ed Korn, PhD
National Cancer Institute
Information on Scientific Program - Pediatric US Network Group Statistics/Data Mgt Center Applicants:
Sally Hunsberger, PhD
National Cancer Institute
Malcolm A. Smith, MD, PhD
National Cancer Institute
Division of Extramural Activities
National Cancer Institute
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Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
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Office of Grants Administration
National Cancer Institute
6120 Executive Blvd., Suite 243
Bethesda, MD 20892 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
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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