Full Text CA-94-014 INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA: CA-94-014 P.T. Keywords: National Cancer Institute Letter of Intent Receipt Date: August 5, 1994 Application Receipt Date: September 21, 1994 PURPOSE The Cancer Therapy Evaluation Program (CTEP) and the Biological Response Modifiers Program (BRMP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) invites research grant applications for the conduct of therapeutic clinical trials research employing new agents, concepts, or strategies for the treatment of cancer. This initiative is aimed at drawing new clinical investigators into this area of research. HEALTHY PEOPLE 2000 The Public Health Service 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 Request for Applications (RFA), Investigator Grants for Clinical Cancer Therapy Research, 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, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. An important principle to remember is that the more extensive the prior independent research experiences, regardless of funding sources, the greater likelihood there will be diminished priority for award. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01) as its funding mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years. The total direct cost for the four year period may not exceed $500,000. The direct cost in any budget period should not exceed $150,000. The anticipated award date is July 1995. 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, the award of grants pursuant to this RFA is contingent upon the continuing availability of funds for this purpose. This RFA is a one-time solicitation for new applications for award in FY 95. However, the NCI has plans to re-issue this RFA for funding in 1996 and 1997. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $1,500,000 in total costs per year for four years will be committed to fund specifically applications submitted in response to this RFA. It is anticipated that eight new individual awards will be made. RESEARCH OBJECTIVES Background In the past year, a number of groups have expressed concern over the declining number of clinical investigators entering and remaining in academic research. Clinical investigators are a critical component in translating new therapeutic agents and modalities from the laboratory into the clinic. They must maintain a broad perspective and knowledge concerning clinical and basic sciences, while developing new cancer therapies that are hypothesis driven. They are highly interactive with basic and clinical researchers in related disciplines. This translational clinician is considered distinct from the clinician who also has a PhD or equivalent training and concentrates on basic research or the clinician who participates in cancer research solely by entering patients on clinical trials. The Clinical Investigations Task Force of the National Cancer Advisory Board and a sub-committee of the American Association of Clinical Oncology (ASCO) have both been addressing the problem of the decreasing number of academic clinical investigators. One of the problems identified is the lack of suitable mechanisms for the training and funding of clinical oriented investigators involved in translating basic research into new cancer treatments. There is no specific program available to train the clinical investigators in the design and conduct of clinical trials and translational research. The traditional grants mechanisms (R01, R29) are under-utilized and often do not fit the needs of young clinical investigators for the support of clinical trials research. The R29 grant mechanism requires the investigator to devote at least 50% effort to a five year project and the yearly budget is limited to approximately $70,000. Most clinicians have major clinical and teaching responsibilities and it is impossible to support both the clinical and laboratory components needed within the budget limitations of an R29 grant. New clinical investigators often do not have the publication or research track record to be competitive for R01 grant support. Thus, very few clinical trial research applications are submitted by new clinical investigators. DCT would like to reverse this trend and encourage new clinical investigators in the conduct of translational clinical trials research. Project Description The Cancer Therapy Evaluations Program and the Biological Response Modifiers Program encourage qualified clinical investigators to develop R01 grant applications for the conduct of cancer clinical trials research on new therapeutic agents and modalities. Grant applications must include clinical trials involving human subjects and designed to ultimately improve cancer survival. The clinical trials must have a strong rationale and be based upon preclinical data generated by the applicant or others that support the underlying hypotheses. New clinical therapeutic trials employing drugs (including differentiating agents), biologics (including cytokines, antibodies), vaccine strategies, radiation, or surgery whether used as a single agent/modality or in combination are appropriate. Investigators are urged especially to address the more difficult therapeutic challenges, including the most common malignancies (e.g., breast, ovarian, prostate). Laboratory studies to monitor patients or to study the mechanism of antitumor effect and resistance should be included. The laboratory studies should be in support of the clinical trial, such that their conduct leads to a greater understanding of the relationship of the therapy and biological changes in the patient or the mechanism of action of an anti-tumor response. Laboratory studies would include pharmacokinetic studies of cytotoxic, immune-modulating, differentiation-inducing, and/or targeted therapeutic agents or relevant pharmacodynamic correlative studies. Measurement of particular biological responses would also be desirable particularly when this information would be relevant to the interpretation of the success or failure of the therapy in individual patients on the clinical trial. It is expected that a significant level of effort, at least 25 percent, will be committed to the research project by the Principle Investigator. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. 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 was reprinted in the Federal Register of March 20, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigator may obtain copies from these sources or from the program staff or contact person listed below. Program staff amy also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 5, 1994, 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 may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is be sent to: Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 APPLICATION PROCEDURES The research grant application form PHS 398, (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 710-0267; and from the NCI program staff listed under INQUIRIES. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. 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 number and title must be typed on line 2a 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 signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Applications must be received by September 21, 1994. If an application is received after that date, it will be returned. 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. B. Application Requirements The application must include the following documentation to be considered for review: o A draft of the clinical protocol must be included in the Appendix. Documentation of the status of Human Subjects and IRB approval should be included. o Documentation for the composition of the proposed study population in terms of gender and racial/ethnic group together with a rationale for its choice must be included in the Human Subjects section. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness and for responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NCI peer review group on the basis of relative competitiveness. The NCI will withdraw from further competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated, using the review criteria stated below, for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies using the following review criteria: 1. Importance, timeliness, and clinical merit of the clinical trials. 2. Quality of data supporting the proposed clinical trial. 3. Scientific and technical merit of the proposed laboratory studies. 4. Relevance of the proposed laboratory studies to the clinical trials. 5. Research training and clinical qualifications of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research. 6. Availability of the resources necessary to perform research. 7. Evidence that appropriate steps have been taken to insure the protection of human subjects. 8. Evidence that the applicant is in compliance with NIH policies regarding the inclusion of women and minorities in clinical research study populations (STUDY POPULATIONS section of this RFA). The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. AWARD CRITERIA Applications considered by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit; (b) availability of funds; and (c) programmatic priorities. Preference will also be given to clinical investigators who are new to this research area. Letter of Intent Receipt Date: August 5, 1994 Application Receipt Date: September 21, 1994 Review by National Cancer Advisory Board: May 1995 Anticipated Award Date: July 1995 INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged. The program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding general programmatic issues to: Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Direct inquiries regarding programmatic issues using biologics to: Dr. Toby Hecht Division of Cancer Treatment National Cancer Institute FCRF 1052, Room 253 Bethesda, MD 20892 Telephone: (301) 846-1098 FAX: (301) 846-5429 Direct inquiries regarding fiscal matters to: Ms. Eileen M. Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 256 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241 and 285) and administered under HHS grants policies. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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