Full Text CA-97-016 MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH GUIDE, Volume 26, Number 24, July 25, 1997 RFA: CA-97-016 P.T. Keywords: NATIONAL CANCER INSTITUTE LETTER OF INTENT RECEIPT DATE: September 23, 1997 APPLICATION RECEIPT DATE: November 18, 1997 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), is continuing the established cancer control effort, which involves practicing oncologists who serve large minority populations in the NCI clinical trials program. The Community Oncology and Rehabilitation Branch (CORB), DCPC, invites applications from domestic institutions with the capability and intent to serve new cancer patients largely from minority populations for cooperative agreements in response to this Minority-Based Community Clinical Oncology Program (Minority-Based CCOP) Request for Applications (RFA). Applicants for new and currently funded Minority-Based CCOPs are invited to respond to this RFA. The NCI clinical trials network provides support for clinical research in cancer centers, major university centers, and community programs. The purpose of this program is to support as a national resource those physicians involved in the care of minority cancer patients who are available for treatment and cancer prevention and control clinical trials research. The linkage of minority cancer patients to the current clinical trials network will also facilitate the transfer of new technology in treatment and cancer prevention and control practices to minority communities and their physicians. The Minority-Based CCOP will: 1) provide support for expanding clinical research in minority community settings; 2) bring the advantages of state-of-the-art treatment and cancer prevention and control research to minority individuals in their own communities; 3) increase the involvement of primary health care providers and other specialists in cancer prevention and control studies; 4) establish an operational base for extending cancer prevention and control and reducing cancer incidence, morbidity, and mortality in minority populations; and 5) examine selected issues in Minority-Based CCOP performance (e.g., patient recruitment, accrual, eligibility). This Minority-Based CCOP RFA seeks to strengthen the Minority-Based CCOP by: 1) continuing the program as a vehicle for supporting community participation in cancer treatment and prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI); 2) expanding and strengthening the cancer prevention and control research effort; 3) utilizing the Minority-Based CCOP network for conducting NCI-assisted cancer prevention and control research; and 4) evaluating on a continuing basis Minority- Based CCOP performance and its impact in the community. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Minority-Based Community Clinical Oncology Program, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic institutions for cooperative agreements to continue the Minority-Based CCOP. Institutions, organizations and/or physician group applicants for the Minority-Based CCOP must have greater than 40 percent of newly diagnosed cancer patients from minority populations. Other eligibility requirements for new applicants and currently funded programs are described below. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. o An applicant may be a hospital, clinic, group of practicing physicians, health maintenance organization (HMO), or consortium of hospitals and/or clinics and/or physicians and/or HMOs that agree to work together with a Principal Investigator and a single administrative focus. o A university hospital that is the major teaching institution for that university AND which has greater than 40 percent of new cancer patients from minority populations is eligible. o A military treatment facility (MTF) or Veterans Administration hospital may be included in an application as a nondominant member of a consortium led by a community institution. o Funded Cooperative Group Outreach Program (CGOP) participants are eligible to apply, but should state in the application that CGOP support will be relinquished if a MBCCOP award is received. o An unfunded non-university clinical trials cooperative group member is eligible. o Funded Minority Satellite Supplement Program (MSSP) participants are eligible, but the application should include a statement that MSSP support will be relinquished if a Minority-Based CCOP award is received. Institutions and organizations NOT eligible to apply as a Minority-Based CCOP include: o A comprehensive, consortial, or clinical cancer center holding an NCI Cancer Center Support (CORE) grant. o A university hospital clinical trials cooperative group member funded by the Division of Cancer Treatment, Diagnosis, & Centers (DCTDC), NCI. o Currently funded Community Clinical Oncology Programs (CCOPs). MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NCI scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NCI purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to this RFA may not exceed 3 years for new applicants and for applicants currently supported under this program. The anticipated award date is June 1, 1998. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will vary also. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. NCI has determined that there is a continuing program need for community participation in cancer clinical research trials, both cancer treatment and prevention and control. This RFA will be published in the NIH Guide for Grants and Contracts periodically, provided funds are available. FUNDS AVAILABLE It is anticipated that up to $2.7 million in total costs per year for 3 years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that up to ten awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. The anticipated amount of the direct cost awards will range from $100,000 to $250,000. Awards for research bases affiliated with Minority-Based CCOPs will be made through Cooperative Agreements under the Community Clinical Oncology Program RFA. NCI program staff will take into account demographic and geographic distributions of peer-reviewed and approved Minority-Based CCOPs in the final funding selection process. Multiple Minority-Based CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. RESEARCH OBJECTIVES A. BACKGROUND The NCI clinical trials network has evolved over the past 30 years. The major NCI program initiatives supporting this network are the Clinical Trials Cooperative Group Program, the Cancer Centers Program, and the Community Clinical Oncology Program (CCOP). Treatment and cancer prevention and control clinical trials research funded through these programs provides patients and their physicians with access to state-of-the-art cancer care management opportunities, and provides oncologists with a source of continuing education on innovations in cancer prevention and control interventions, diagnostic techniques, and treatment applications. One of the major efforts of NCI has been to design and implement program interventions to assure that patients treated in their own communities have access to the same quality of cancer care and the same technological advances available to patients treated in major centers. The CCOP, which was first initiated in 1983, has proven to be a successful model for bringing the benefits of clinical research to cancer patients in their communities by providing support for community physicians to enter patients on treatment research protocols. In addition to increasing patient accrual to treatment clinical trials, the CCOP stimulated many communities to organize their cancer activities and expedited the development of local-regional cancer programs. Increased numbers of physicians, hospitals, and other health care professionals participated in CCOP, accruing patients and meeting the same quality control standards as other members and affiliates. In 1987, the CCOP expanded the cancer prevention and control effort to include support for research in prevention, health promotion, smoking cessation, chemoprevention, treatment applications, continuing care and rehabilitation. With the development and implementation of cancer control research through the clinical trials network, opportunities exist for the implementation of effective preventive strategies for reducing cancer incidence, morbidity, and mortality. When compared to the general population, African- Americans have an increased incidence of a number of malignancies and worse overall survival rates. Greater involvement in clinical trials research by Black, Hispanic, Asian-American, American Indian, and other racial/ethnic minority patients is needed if the advances in clinical research are to be extended to all groups, and the results of clinical trials generalizable to the entire population. In general, there has been limited participation in clinical trials research by minority cancer patients. Broader access to clinical research protocols is needed in order to develop and implement effective treatment and cancer prevention and control strategies in minority populations. Areas of research where minority involvement is especially needed include: cancer prevention and control interventions to improve screening and early detection practices; methodological research on ways to increase the educational awareness of individuals at risk for cancer; and studies of barriers to prevention and treatment applications. The Minority-Based CCOP has become an important part of these efforts. It links physicians caring for large numbers of minority patients to the NCI clinical trials network. The CCOP model has been an effective mechanism for facilitating the linkage of investigators and their institutions with the clinical trials network. The Minority-Based CCOP was initially approved by the NCI, Division of Cancer Prevention and Control Board of Scientific Counselors in January 1989. Implementation began in the fall of 1990. By 1992 the program was beginning to succeed in its goal of providing minority populations access to clinical trials. In the year ending 1996, there were eight programs in seven states, and Puerto Rico involving approximately 35 hospitals (9 affiliates and 26 components) and over 300 physicians. Approximately 70 percent of Minority-Based CCOP patients entered on study during that period are from minority populations. In one study, 14.1 percent of all patients entered onto NCI-sponsored treatment trials were from ethnic minorities. These Minority-Based CCOPs contributed more than 10 percent of all minority accrual to NCI-sponsored cancer treatment trials. B. GOALS AND SCOPE The Minority-Based CCOP initiative is designed to: o Bring the advantages of state-of-the-art cancer treatment and prevention and control research to minority individuals in their own communities by having practicing physicians and their patients/subjects participate in NCI-approved cancer treatment and prevention and control clinical trials; o Provide a basis for involving a wider segment of the community in cancer prevention and control research and investigate the impact of cancer therapy and control advances in community medical practices; o Increase the involvement of primary health care providers and other specialists (e.g., surgeons, family practitioners, urologists, gynecologists) with the Minority-Based CCOP investigators in cancer treatment and prevention and control research, providing an opportunity for education and exchange of information; o Facilitate wider community participation among racial/ethnic minorities, women, and other under served populations in cancer treatment and prevention and control research approved by NCI; o Provide an operational base for extending cancer control and reducing cancer incidence, morbidity, and mortality in minority populations by accelerating the transfer of newly developed cancer prevention, early detection, treatment, patient management, rehabilitation, and continuing care technology to widespread community application; and o Examine selected issues in Minority-Based CCOP performance (e.g., patient recruitment, accrual, eligibility, patient behavioral modification) and evaluate its impact in the community. Participating community programs (Minority-Based CCOPs) will be required to enter patients/subjects onto NCI-approved cancer treatment and prevention and control clinical trials through the research base(s) with which each Minority-Based CCOP is affiliated. Minority-Based CCOPs may relate directly to NCI for assistance and participation in selected cancer prevention and control protocols. Minority- Based CCOP performance will be evaluated on a continuing basis by the NCI program director. Minority-Based CCOP applicants must demonstrate the potential for accessing appropriate cancer patients/subjects within their communities for participation in cancer treatment and prevention and control protocols provided by their research bases. SPECIAL REQUIREMENTS In addition to the customary programmatic and financial negotiations that occur in the administration of grants, the following terms and conditions pertaining to the scope and nature of the interaction between NCI and the investigators will be incorporated in the Notice of Award; they are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; DHHS grant administration regulations 45 CFR 74; other DHHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms of award. TERMS AND CONDITIONS OF AWARD The administrative and funding instrument used for this program is a cooperative agreement (U10), and anticipated assistance to awardees from the NCI Program Staff will include: clarification of Minority-Based CCOP requirements; review of accrual to clinical trials; monitoring of community efforts to increase minority participation in clinical research; participation in protocol review; and discussions on the continuing needs of the program for enhancing Minority-Based CCOP performance. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partnership role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Staff. A. RESPONSIBILITIES OF MINORITY-BASED CCOP AWARDEES The awardee's programmatic responsibilities for the conduct of the research supported by this cooperative agreement are described in the INVESTIGATOR'S HANDBOOK, a Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment, Diagnosis, and Centers (DCTDC), National Cancer Institute and the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES and any subsequent modifications of this document. These documents are hereby incorporated by reference as term of award and are available on request from the Cancer Therapy Evaluation Program (CTEP), DCTDC or the CORB/DCPC. 1. Protocols All protocols used by Minority-Based CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), Division of Cancer Prevention and Control (DCPC) and/or the Protocol Review Committee (PRC), Division of Cancer Treatment, Diagnosis, and Centers (DCTDC), NCI, prior to implementation. To be eligible to receive credit for accrual to a research base protocol, the Minority-Based CCOP must have an affiliation agreement with the research base responsible to NCI for that protocol. The research base is responsible for the development and implementation of high-quality cancer treatment and control clinical trials and for evaluation of the results of such studies. 2. Research Base Affiliation(s) Each Minority-Based CCOP must affiliate with a national multi specialty cooperative group (research base) having a spectrum of cancer treatment and prevention and control clinical trials. A Minority-Based CCOP cannot affiliate with more than one national multi specialty cooperative group. Each Minority-Based CCOP may also affiliate with a maximum of four additional research bases. Note: A list of currently eligible research bases may be obtained from the program official listed in the Letter of Intent Section. If participation in the protocols of one group competes with that of another group with which the Minority-Based CCOP is affiliated, the Minority-Based CCOP must prioritize the protocols in order to avoid bias in the allocation of patients to competing protocols. Initial affiliations should be maintained for the duration of the funding cycle. When circumstances require changes in research base affiliations, prior written approval from the DCPC Program Director is required. 3. Accrual Patient accrual to clinical trials is expected to be reflective of the new cancer patient distribution of the participating physicians; that is, greater than 40 percent of new cancer patients from minority populations. As one measure of performance, it is expected that at least 10 percent of all new cancer patients for whom protocols are available will be placed on clinical trials are maintained by minority patients of Minority-Based CCOP physicians. Each Minority-Based CCOP is required to accrue a minimum of 50 credits* per year to treatment clinical trials that have been approved by the PRC, DCTDC, NCI. For applicants whose specialty is pediatrics, the 50 treatment credit minimum requirement may be waived for those applicants who are able to place a majority of their eligible patients on protocols. Each Minority-Based CCOP is eventually required to accrue a minimum of 50 credits* per year to cancer prevention and control clinical trials that have been approved by the CCPRC, DCPC. Cancer prevention and control research should be intervention-oriented and may include such areas as cancer prevention, early detection, patient management, rehabilitation, and continuing care. New applicants for the Minority-Based CCOP award are required to accrue a minimum of 30 cancer control credits* in the first year of funding, 40 credits in the second year, and 50 credits thereafter in cancer prevention and control. Existing Minority-Based CCOPs undergoing competitive continuation are expected to accrue a minimum of 50 credits per year in cancer treatment and 50 credits per year in prevention and control. The Minority-Based CCOP's ability to meet projected accrual goals to both cancer treatment and prevention and control clinical trials will also be assessed. The ability to incrementally accrue and maintain minority enrollment will be assessed and weighted toward credits gained. For Minority-Based CCOPs that have demonstrated an outstanding record of accrual to cancer prevention and control clinical trials, the 50 credit minimum for treatment may be waived. * Each protocol approved for CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. For example, each patient accrued to an average Phase II or Phase III treatment protocol will count 1 credit; a NCI-designated high-priority protocol, 1.5 credits; and a childhood acute lymphocytic leukemia protocol, 2 credits. Cancer prevention and control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per subject entered. Cancer control protocols involving limited interventions will receive credit that is commensurate with the amount of data management effort required, usually an assignment of 0.3 or 0.5 credit per subject entered. Follow-up credit for chemoprevention protocols may also be awarded. 4. Quality Control The Minority-Based CCOP must establish and follow procedures for the assurance of data quality and quality control in accordance with research base guidelines and NCI policies. The Minority-Based CCOP must follow NCI- approved procedures developed by the research base for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected by the research base. The Minority-Based CCOP must follow policies developed by the research base and approved by the NCI for auditing the accuracy of scientific data submitted to them by the research base participants. 5. Data Management The Minority-Based CCOP must provide the DCPC Program Director with access to all data generated under this award for periodic review of data management procedures of the Minority-Based CCOP. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA, and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data. 6. Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. 7. Organizational Changes Certain Minority-Based CCOP organizational changes must have the prior written approval of the DCPC Program Director. These include the addition/deletion of a participating physician, a health care professional other than a physician (who actively enters patients to cancer prevention and control trials), an affiliate, component, or research base. 8. Radiotherapy Equipment Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in protocols requiring radiation therapy, as required by the affiliated research base(s). 9. Monitoring Each Minority-Based CCOP must agree to periodic on-site audits by representatives of its research base(s), NCI, or an NCI-designee. Such on-site audits may include review of the following: use of investigational drugs; compliance with regulations for institutional review board IRB approval and informed consent (compliance with 45 CFR 46); compliance with protocol specifications; quality control and accuracy of data recording; and completeness of reporting adverse drug reactions. Research Base evaluation reports of such on-site audits will be reviewed by the Clinical Trials Monitoring Branch (CTMB), Cancer Therapy Evaluation Program (CTEP), DCTDC, and by the DCPC Program Director. In addition, NCI program and grants management staff will review protocol accrual, fiscal, and administrative procedures. All institutions participating or collaborating in the Minority-Based CCOPs on NCI-supported multi- institutional clinical trials must be in compliance with the monitoring standards established by the research base. These should include the following standards: o Medical records submitted in support of NCI multi- institutional trials must conform to usual standards for the maintenance of clear, accurate, and unambiguous medical records. White-outs on medical records are unacceptable. o If it is the usual and customary practice of a department, laboratory, clinic or office to prepare or issue official reports, then only that department, laboratory, clinic or office can change the report, and alterations of the medical record must be initialed and dated by the person making such alterations. For clinical progress notes, the change must be dated and initialed by the person making the change. Only one line should be placed through the initial entry, so that both the original entry and the change are legible. o The improper modification of important patient records will result in additional investigations by the NCI Clinical Trials Monitoring Branch (CTMB) and may lead to suspension of accrual and funding. 10. Reporting Requirements Annual progress reports must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The inability of a Minority-Based CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension, or termination of the award. 11. Network Participation Minority-Based CCOPs are part of a national network for conducting cancer treatment and prevention and control clinical trials. As such, each Minority-Based CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the program and its impact in the community. Minority-based CCOPs may also be asked to share their process and outcome methods for recruiting and maintaining minority enrollment. 12. Patient/Subject Log Each Minority-Based CCOP will be asked to periodically maintain and verify a new patient/subject log or minimal registry to include age, sex, race, ethnicity, insurance status, risk factors, primary site of cancer, stage of disease, and disposition for the potentially eligible patient/subject pool seen by the Minority-Based CCOP investigators. 13. Federally Mandated Regulatory Requirements Each Minority-Based CCOP must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. At a minimum, these include: o methods for assuring that each facility at which CCOP investigators are conducting clinical trials has a current, approved assurance on file with the Office for Protection from Research Risks (OPRR); that each protocol is reviewed by the responsible IRB prior to patient entry; and that each protocol is reviewed annually by the IRB so long as the protocol is active; o methods for assuring or documenting that each patient (or patient's parent/legal guardian) gives fully informed written consent to participation in a research protocol prior to the initiation of the experimental intervention; o a system for assuring timely reporting of all serious and unexpected toxicities to the Investigational Drug Branch, CTEP, DCTDC, according to DCTDC guidelines and/or to DCPC according to DCPC guidelines; and o implementation of DCPC/DCTDC requirements for storage and accounting for investigational agents provided under DCPC/DCTDC sponsorship. 14. Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgment of NCI support. B. NATURE OF NCI STAFF INVOLVEMENT 1. Protocol Review All protocols used by the Minority-Based CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), Division of Cancer Prevention and Control (DCPC) and/or the Protocol Review Committee (PRC), DCTDC, NCI, prior to implementation. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved or that has been closed (except for patients already on study). 2. Monitoring There will be periodic on-site audits of each Minority-Based CCOP by representatives of its research base(s), NCI, or an NCI-designee, such as DCTDC's current Clinical Trials Monitoring Service contractor. The DCPC and CTMB/CTEP will review and provide advice regarding mechanisms established for study monitoring, including the on-site auditing program. DCPC/CTEP and/or its contractor staff may attend the on-site audits conducted by the research base or its NCI designee as observers. 3. Data Management The DCPC Program Director will have access to all data generated under this award and will periodically review the data management procedures of the Minority-Based CCOPs. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the Food and Drug Administration (FDA). 4. Investigational Drug Management The Regulatory Affairs Branch (RAB), Pharmaceutical Management Branch (PMB), CTEP, DCTDC and Chemoprevention Investigational Studies Branch (CISB), Chemoprevention Research Program (CPRP), and DCPC staff will advise investigators of specific requirements and changes in requirements about investigational drug management that the FDA and NCI may mandate. 5. Organizational Changes The DCPC Program Director will review requests for certain organizational changes and provide written approval. These changes include the addition/deletion of a participating physician or other health professional entering patients/subjects in cancer prevention and control research in the Minority-Based CCOP, an affiliate, component, or research base. 6. Program Review The DCPC Program Director will review the annual progress report submitted by each Minority-Based CCOP. A suggested format will be developed by the DCPC Program Director for this purpose. The DCPC Program Director will review the progress of each Minority-Based CCOP through consideration of the Minority-Based CCOP annual report, program site visits, and reports from affiliated research bases. This review may include, but not be limited to, overall accrual credits, percent of available patients/subjects placed on study, eligibility and evaluability of individuals entered on study, and timeliness and quality of data reporting. The inability of a Minority-Based CCOP to meet the performance requirements set forth in the Terms and Conditions of Award, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 7. Strategy Sessions The DCPC Program Director or designee will sponsor strategy sessions when indicated, attended by principal investigators from the Minority-Based CCOPs and appropriate DCPC/DCTDC staff. At these meetings, information relevant to the Minority-Based CCOPs will be reviewed and discussed, including such issues as overall Minority-Based CCOP performance and the science of current or proposed clinical trials. Data will be analyzed and the outstanding research questions established and prioritized into national research goals by Minority- Based CCOP investigators and the DCPC/DCTDC attendees. The principal investigators will have the primary responsibility for analyzing and prioritizing the research questions to be developed into clinical trials. The DCPC Program Director will also assist the Minority-Based investigators in exploring mutual interests in cancer prevention and control research. 8. Federally Mandated Regulatory Requirements The DCPC Program Director or designee and DCTDC staff will review mechanisms established by each Minority-Based CCOP to meet the Department of Health and Human Service (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. C. ARBITRATION PROCESS NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the involved NCI Program Staff on programmatic decisions of scientific or technical matters. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, DCPC. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which were published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit by September 23, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent should be sent to: Lori Minasian, MD, FACP Acting Chief, Community Oncology & Rehabilitation Br. Division of Cancer Prevention and Control, NCI Executive Plaza North, Room 300 6130 EXECUTIVE BLVD, MSC-7340 Bethesda, Maryland 20892-7340 Telephone: (301) 496-8541 Fax: (301) 496-8667 E-mail: MinasiaL@dcpcepn.nci.nih.gov APPLICATION PROCEDURES A. PREPARATION OF APPLICATIONS General instructions for the preparation of the cooperative agreement application are contained in the research grant application Form, PHS-398 (rev. 5/95). Responses to the instructions concerning "Human Subjects" verification must be provided when the application is initially submitted. Because the Terms and Conditions of Award (discussed in the SPECIAL REQUIREMENTS Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded program will be a competitive continuation and must include a progress report that, at a minimum, consists of the following: 1. A summary of prior Minority-Based CCOP activities/ accomplishments, including: a clear presentation of yearly accrual over the funding period; accrual tables from previous annual progress reports; a summary of accrual to all cancer treatment and a summary of accrual to all cancer prevention and control protocols by gender and ethnicity; and progress in meeting DCPC's established accrual goals. 2. A plan for continuing to meet prevention and control accrual requirements, including plans for follow-up of subjects from the large prevention trials as well as plans for implementation of additional cancer control protocols. 3. Tables of the current budget and FTEs with a justification for any request for additional resources. 4. An evaluation of Minority-Based CCOP performance by affiliated research base(s). 5. A complete description of how the applicant has met the special cooperative agreement terms and conditions of the award including staffing patterns that may have significantly contributed to minority involvement in clinical trials. Both new and currently funded applicants should address the following: 1. Each applicant must demonstrate access to a population with greater than 40 percent of new cancer patients from minority groups and must include plans for recruiting and maintaining women and minority participants. Data from hospital registries, admission, discharge, clinic, and billing records may be used to document the new minority cancer patient population available to the applicant organization AND its physician participants. 2. Each applicant must delineate its catchment area. A map of the service area should be provided, designating counties or zip codes from which approximately 80 percent of the patients will be drawn. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) that are not part of the application should be included. In describing the study population, a breakdown, by percentage of the gender and minority composition of the study population, should be provided. This information may be based on the institutional records and/or prior experience. 3. Each applicant must demonstrate the potential and stated commitment to accrue a minimum of 50 credits per year to treatment clinical trials (except if waived for applicants whose specialty is pediatrics). Documentation must include any prior participation in treatment research clinical trials with a clear presentation of the number of patients and credits accrued to NCI-approved treatment clinical trials. A list of the NCI-approved treatment protocols in which the applicant expects to participate and the projected accrual to each must be provided. 4. Each new applicant must demonstrate the potential and plans for accrual of a minimum of 30 credits in the first year of funding, 40 credits in the second year, and 50 credits in the third year to cancer prevention and control protocols. Documentation must include any prior participation in cancer prevention and control research clinical trials with a clear presentation of the total number of patients and credits accrued to NCI-approved cancer prevention and control clinical trials. A list of the NCI-approved prevention and control protocols in which the applicant expects to participate and the projected accrual to each must be provided. 5. New applicants must provide at least two examples of NCI-approved intervention cancer prevention and control protocols appropriate for Minority-Based CCOP participation. For these two protocols, the applicant should describe their implementation, including specifics on patient/subject recruitment, compliance, and follow-up. These studies must come from research bases with which they propose to affiliate. The Minority-Based CCOP applicant must document the ability to access the appropriate physicians and patient/ subject populations and adequate facilities to participate in the proposed clinical trials. 6. A designated Principal Investigator is required. An associate Principal Investigator should also be named to assure continuity in the event of resignation of the Principal Investigator. The qualifications and experience of both must be described in terms of ability to organize and manage a community oncology program which includes cancer treatment and prevention and control research and related activities. 7. Each applicant is expected to have a committed multi disciplinary professional group appropriate for its expected protocol participation. This team may include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family practice) as appropriate. Where appropriate, each applicant should include plans to utilize minority professionals to assure accrual success. The training and experience of participating physicians must be provided, along with a description of working relationships. Any experience working together as a group, particularly in implementing clinical cancer treatment and prevention and control research and related activities, should be included. An organizational chart showing how the group will function must also be included. Special personnel resources needed to support the recruitment and retention of eligible minority patients on clinical trials may be requested. 8. Each applicant must provide the qualifications and experience of all proposed support personnel as well as a description of the proposed duties for each position. 9. Through formal affiliations with a maximum of five research bases, only one of which may be a national multi specialty cooperative group, each applicant must demonstrate access to both cancer treatment and prevention and control research protocols. Evidence must be provided that an affiliation has been established with at least one NCI-funded research base that has the capacity to provide both clinical cancer treatment and prevention and control protocols. In addition, affiliations with research bases offering only cancer prevention and control protocols are appropriate. The conditions of affiliation must be provided in the Minority-Based CCOP-research base affiliation agreement(s). Initial affiliations should be maintained during the funding cycle. Multiple research base affiliations are permitted provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing protocols will be resolved. Note: A list of currently eligible research bases may be obtained from the program official listed in the Letter of Intent Section. 10. Quality control procedures must be described in detail. Assurance of quality is the joint responsibility of the Minority-Based CCOP and its research base(s). Quality control procedures of the research base will be applied to the Minority-Based CCOPs and should be specified in the affiliation agreement between the Minority-Based CCOP and the research base. Procedures for investigational drug monitoring and data management must also be described. 11. The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization and/or documentation of consortium arrangements must be provided. Evidence of involvement with community-based voluntary organizations may be submitted. In addition, each applicant must have a defined space for administrative activities and administrative personnel which will serve as a focus for data management, quality control, and communication. 12. Allocation of funds to support community costs for receipt, handling, and quality control of patient data must be specified. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., reimbursement of patient care expenses; transportation costs). Funding is not allowed for clinical support personnel (e.g., pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on Minority- Based CCOP organizational/administrative tasks. Justification must be provided for personnel time, effort, and funds requested. METHOD OF APPLYING The research grant application form PHS-398 (Rev. 5/95) must be used in applying for cooperative agreements. These forms are available at most institutional business offices; from the Office of Extramural Research and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, Maryland 20892-7910 (Telephone: 301/710-0267; E-mail: asknih@odrockml.od.nih.gov); and from the NCI program official named in the LETTER OF INTENT Section. A suggested format will be sent to all applicants requesting an RFA or submitting a letter of intent. All applicants are encouraged to obtain and use the suggested format instructions for organizing the specific information concerning the RFA programmatic requirements in the PHS 398. The RFA label available in the PHS-398 (Rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three (3) signed, exact photocopies, in one package to DRG at the address listed below. The photocopies must be clear and single-sided. DIVISION OF RESEARCH GRANTS National Institutes of Health 6701 Rockledge Dr., Rm 1040 Bethesda, Maryland Express Mail: Bethesda, MD 20817 At the time of submission, two (2) additional copies of the application must also be sent to the National Cancer Institute at the address listed below: Ms. Toby Friedberg Review Logistics Branch Division of Extramural Activities National Cancer Institute Executive Plaza North - Room 636 6130 Executive Boulevard Bethesda, Maryland 20892 Express Mail: Rockville, Maryland 20852 It is important to send these copies at the same time that the original and three (3) copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received on or before the designated receipt date. Applications must be received by November 18, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS A. REVIEW PROCEDURES Upon receipt, applications will be reviewed for completeness by DRG staff and for responsiveness by NCI staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will return it. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applicants will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the appropriate National Cancer Advisory Board. B. REVIEW CRITERIA 1. Ability to access through participating Minority-Based CCOP physicians a population with greater than 40 percent of new cancer patients from minority groups. In describing the study population, it is required that a description of the gender and minority population served be provided, including an outreach plan and as appropriate utilization of minority personnel. This information may be based on institutional records and/or prior experience. 2. For new applicants, ability to accrue a minimum of 50 credits per year to treatment clinical trials and a minimum of 30 credits per year to cancer prevention and control clinical trials in the first year, increasing to 50 credits per year in the third year. Established Minority-Based CCOPs will be funded at a yearly accrual goal that may be higher than 50 credits for treatment clinical trials and 50 credits for cancer prevention and control clinical trials. These established Minority-Based CCOPs will be evaluated for their past performance in meeting these accrual goals. The minimum treatment accrual requirement may be waived for applicants whose specialty is pediatrics. Each applicant's ability to access the appropriate populations, professional disciplines, and facilities to participate with affiliated research bases in NCI-approved cancer prevention and control intervention protocols will be appraised. Any prior participation in cancer treatment and prevention and control research will be considered. 3. Qualifications, experience and track record of the Principal Investigator/ associate Principal Investigator, in terms of ability to organize and manage a community oncology program that includes both cancer treatment and prevention and control research and related activities. 4. Training, experience, and commitment of participating physicians for accruing individuals to protocols in which the applicant has agreed to participate. The experience of proposed investigators in the entry and treatment of cancer patients on research trials (gained from residency, fellowships, postdoctoral training and/or subsequent practice) will be appraised. For multidisciplinary studies, evidence of the availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, pathology, internal medicine, family practice, nursing, and nutrition) will be required. Experience or special skills in cancer prevention and control research and related activities will be considered, together with availability of other community resources and personnel for such clinical trials. 5. Stability of the functional unit or group applying to become a Minority-Based CCOP. Preexisting organizational affiliations of at least a core of the group applying and evidence of stable working relationships will be appraised. Examples of established consortium arrangements and committee structure which demonstrate the participation of appropriate physicians and administrators may be submitted. Evidence of previous success as a group in implementing clinical cancer treatment and prevention and control research and related activities will be considered. 6. Qualifications and experience of all proposed support personnel relative to their position descriptions. The relevant credentials and expected contributions to the program of personnel resources not fiscally supported by the award will be considered. 7. Adequacy of quality assurance mechanisms for both cancer treatment and prevention and control interventions, and adequacy of procedures for investigational drug monitoring and data management identification of false or otherwise unreliable data. 8. Adequacy of available facilities, including laboratories, in-patient and outpatient resources, cancer registries, etc., and adequacy of space for administrative activities and personnel. 9. Appropriateness of research base affiliations and of the cancer treatment and prevention and control research protocols chosen. Affiliation agreements must be provided in the application. 10. For competitive continuations, adequacy of progress during the funding period, including ability to meet the minimum accrual credits in cancer treatment and prevention and control, progress made as a Minority-Based CCOP, and evaluation of Minority-Based CCOP performance by affiliated research base(s). Deliberation will be given to previous accrual and the ability to meet the previous accrual projections for which the Minority-Based CCOP was funded. Minority-Based CCOP evaluation by affiliated research bases must be provided. Plans for continued accrual and follow-up of subjects on protocols will be evaluated. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Special personnel resources needed to support the recruitment and retention of eligible minority patients on clinical trials will be considered. Funding is not allowed for clinical care provided to patients. (e.g., patient care reimbursement, transportation costs). Funding is not allowed for clinical support personnel (e.g., pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on Minority-Based CCOP organizational/administrative tasks. Justification must be provided for personnel time and effort and funds requested. The initial review group will also examine the provisions for the protection of human subjects, recruitment plans for the inclusion of women, minorities and subpopulations to clinical trials, and the safety of the research environment. AWARD CRITERIA The anticipated date of award is June 1, 1998. NCI program staff will take into account demographic and geographic distribution of applicants in the final funding selection process to assure inclusion of minority and under served populations. Multiple Minority-Based CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. INQUIRIES Written or telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and should be directed to Dr. Lori Minasian at the address provided in Letter of Intent. The Program Director welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding fiscal matters to: Ms. Crystal Wolfrey Grants Administration Branch Office of the Director, NCI Executive Plaza South, Room 243 Bethesda, Maryland 20892 Telephone: (301) 496-7800, Ext. 282 Email: WolfreyC@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |