Full Text CA-95-012 INVESTIGATOR GRANTS FOR CLINICAL CANCER THERAPY RESEARCH NIH GUIDE, Volume 24, Number 15, April 28, 1995 RFA: CA-95-012 P.T. 34 Keywords: Cancer/Carcinogenesis Treatment, Medical+ National Cancer Institute Letter of Intent Receipt Date: September 1, 1995 Application Receipt Date: October 20, 1995 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 encouraging new clinical investigators who have not previously had independent grant funding to submit research applications in this area of research. 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 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 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 direct cost for the four year period may not exceed $500,000. The direct cost in any budget period may not exceed $150,000. The anticipated award date is July 1996. 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 96. NCI encourages investigators who responded to the previous solicitation (RFA CA-94-014) to resubmit. The NCI has plans to re- issue this RFA for funding in 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 $2,000,000 in total costs per year for each of four years will be committed to fund applications submitted in response to this RFA. It is anticipated that ten 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. 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 percent 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, who have not previously received R01 or R29 grant support, to submit grant applications for 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, preferably generated by the applicant or collaborators, 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, prostrate, lung). 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. If so, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. 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 4928 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 provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 1, 1995, 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 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Bethesda, MD 20852 (for express mail) Applications must be received by October 20, 1995. 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 RFA 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. Special Instructions for the Completion of the PHS 398 Application NIH has recently been designated a "re-invention laboratory" by the Public Health Service. One component of our efforts to streamline NIH operations is to simplify the grant application and review process. Therefore, an experiment is being conducted to determine ways to reduce the administrative burden in applying for an NIH grant without compromising those elements needed by the initial scientific peer review group to assess the scientific merit of the application and the reasonableness of the proposed budget. In responding to the RFA, the following are specific instructions for sections of the PHS 398 application form (rev. 9/91) that should be completed differently from usual. Some sections are modified and others in the application do not need to be completed for the submission of the application but WILL be requested if your application receives a priority score in the fundable range. For all other items in the application, follow the usual instructions on pages 9-32 of the PHS 398 booklet. FACE PAGE (Form AA) - The title and number of the RFA must be typed in line 2a. Failure to do so could result in delayed processing of your application such that it may not reach the review committee in time for review. Item 10, INVENTIONS AND PATENTS - Do not complete. See Specific Instructions - Appendix for Instructions. FORM DD - PAGE 4 - DETAILED BUDGET PAGE FOR INITIAL BUDGET PERIOD Enter direct costs only for the following: o Personnel, Patient Care Costs, Alterations-Renovations - Complete these sections as instructed in the PHS 398 booklet. o Consultant Costs - Itemize only if proposed consultant costs exceed $10,000 or if a consultant is identified as key personnel. o Equipment - Itemize only individual equipment items in excess of $10,000. o Supplies - Itemize (a) all animal costs and (b) any individual supply item which costs more than $10,000. If animals are involved, state their unit purchase and care costs. Enter total animal costs and supply costs on separate lines. o Travel and Other Expenses - Itemize any expense category that exceeds $5,000. Form EE - Page 5 - BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD - Do not complete this page. Unless you are requesting unusual increases or decreases in future years, they will be automatically escalated on the direct costs proposed for the first year (minus one time costs for equipment) by four percent. Form FF - Page 6 - BIOGRAPHICAL SKETCH - For each KEY person only, provide a two-page biographical sketch. Name, Position Title, Education - Complete these sections as instructed in the PHS 398 booklet. Research and Professional Experience - Identify your research background and experience relevant to the research proposed. Specifically, provide: o A list of previous research positions that are felt to be of significance or relevance for the review of the proposed research; o Complete references, titles, and authors on all peer-reviewed publications representative of your research career or pertinent to the research proposed; o The title and funding source of all active research grants or contracts on which you are principal investigator, co-investigator, or project leader. Indicate current percent effort for each award. o The title and length of service on any peer review group, council, or program advisory committee. Form GG - Page 7 - OTHER SUPPORT - Do not complete. Updated information will be requested by NCI staff from only those applicants being considered for funding. Form HH - Page 8 - RESOURCES AND ENVIRONMENT - Complete this section as requested in the PHS 398 form. SPECIFIC INSTRUCTIONS - RESEARCH PLAN (Booklet Pages 19-24) - Applications in response to this RFA should be concise and shorter than regular grant applications. Items 1-4 may not exceed 20 pages in total. Item 1 - Specific Aims - In one page or less, list in priority order, the broad, long-range objectives. Describe concisely and realistically the hypothesis to be tested and what the specific research described in this application is intended to accomplish. Item 2 - Background and Significance - In two to three pages, use this section to describe (a) how the proposed research will contribute to meeting the goals and objectives of the RFA; and, (b) explain the rationale for the selection of the general methods and approaches proposed to accomplish your specific aims. Items 3-4 - Progress Report/Preliminary Studies, Research Design and Methods - In seventeen pages or less, complete as instructed on pages 20-21 of the PHS 398 booklet with the modification that the clinical protocol(s) and up to six publications, manuscripts submitted or accepted for publication, patents, or invention reports can be included in the Appendix (see below). Investigator may use this section to address the following: o preliminary studies pertinent to the application; o rationale and hypothesis for the clinical trial and laboratory studies. o general methods that will be utilized; provide specific details for those techniques which are unique or where a significant departure from a generally accepted technique is important for reviewers to know; o outcome measures that will be used to assess the success or failure of each set of experiments (include statistical analyses for laboratory and clinical studies); o plans for the rigorous data management and verification of research data; o potential pitfalls in the experimental design and alternative studies that will be done if the proposed experiments fail. Items 5-6 - Human Subjects, Vertebrate Animals - Complete as described on pages 22-23. State clearly the plans for early detection of and protection against adverse effects on human subjects. 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. Item 7 - Consultants/Collaborators - Biographical sketches should conform to the brief format described previously for Form FF. Item 8 - Consortium, Contractual Arrangements - In one page or less, provide a brief explanation of the programmatic fiscal and administrative arrangements made with collaborating organizations. Item 9 - Literature Cited - In five pages or less, give full literature citations including the title of the article. SPECIFIC INSTRUCTIONS - APPENDIX (Page 24) - Up to ten publications, manuscripts submitted or accepted for publication, patents, and invention reports may be provided. Clinical protocol(s) must be included in this section. Other than this change, complete as instructed. Questions regarding these instructions may be directed to the program staff listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness and by the NCI for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff may 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 that are complete and responsive to the Request for Applications 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 applications 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 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 in the area of the proposed research. 6. Availability and quality of the resources necessary to perform research. 7. Quality of data verification and management plans and statistical analysis. The initial review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. They will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. 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: September 1, 1995 Application Receipt Date: October 20, 1995 Review by National Cancer Advisory Board: May 1996 Anticipated Award Date: July 1996 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 and chemotherapy agents to: Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 6130 Executive Boulevard MSC 7432 Bethesda, MD 20892-7432 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: BRONZERD@DCT.NCI.NIH.GOV Direct inquiries regarding programmatic issues using biologics to: Dr. Toby Hecht Division of Cancer Treatment National Cancer Institute FCRDC 1052, Room 247 Bethesda, MD 20892 Telephone: (301) 846-1098 FAX: (301) 846-5429 Email: HECHT@NCIFCRF.GOV Direct inquiries regarding fiscal matters to: Ms. Eileen M. Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 256 FAX: (301) 496-8601 Email: NATOLIE@GAB.NCI.NIH.GOV 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 PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use 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 routing 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. .
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