EXPLORATORY STUDIES IN CANCER DIAGNOSTICS Release Date: January 16, 1998 PA NUMBER: PA-98-022 P.T. National Cancer Institute PURPOSE The Diagnostics Research Branch of the Cancer Diagnosis Program in the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI) invites research grant applications from interested investigators to conduct innovative studies in cancer diagnostics. Advances in understanding of basic cancer biology and the development of powerful molecular technologies are leading to the identification of many new abnormalities in cancer cells. These novel tumor characteristics can provide information to enhance that obtained from the histopathologic features traditionally used to diagnose cancers. The objective of this Program Announcement is to encourage applications from individuals who are interested in testing novel ideas that are scientifically sound and may advance progress in cancer diagnosis. The R21 grant mechanism is utilized for pilot projects or feasibility studies to support exploratory research that may produce innovative advances in science. This grant program provides limited funds (maximum of $75,000 direct costs per year not including indirect costs of any collaborating institutions) for short-term (up to two years) research projects. 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 PA, Exploratory Studies in Cancer Diagnostics, 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- 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) exploratory/developmental grant (R21) mechanism. Applicants will be responsible for the planning, direction and execution of the proposed project. All PHS and NIH grants policies will apply to the applications received and awards made in response to this program announcement. Applicants may request up to $75,000 per year in direct costs. (Indirect costs for collaborating institutions, if any, will not be counted against this limit.) The total project period for an application submitted in response to this PA may not exceed two years. These grants are non-renewable, and continuation of projects developed under this program will be through the traditional unsolicited investigator-initiated research grant program. RESEARCH OBJECTIVES Background The Cancer Diagnosis Program supports the development of better tools to aid in the clinical management of cancer patients. Although clinical need drives this process, much of the early research remains descriptive, focusing on the search for apparent differences between tumor and normal cells. When differences are found, an attempt must be made to correlate the changes with clinical parameters. The further development and evaluation of the approach will depend on whether it will answer a clinical question. It has been difficult for investigators to obtain support for early translational studies through the traditional research project grant (R01) mechanism. Such studies may not be sufficiently developed for a standard R01 and may be considered high-risk. The exploratory grant (R21) mechanism is more appropriate for these investigations. We expect that these R21 grants will serve as a basis for planning future clinical research project (R01) grant applications or NCI cooperative clinical trial group studies. Because the exploratory grant mechanism is designed to support innovative ideas, extensive preliminary data as evidence of feasibility are not required. However, the applicant must develop a sound research plan. The opportunity for discovery of new information about the behavior of tumor cells and the potential significance of the information to be obtained are major considerations in the evaluation. Research Goals and Scope The major goal of this initiative is to promote the discovery of new molecular or cellular abnormalities in tumors that will be useful for cancer diagnosis. Investigators are encouraged to consider the broadest range of biological alterations in tumor cells and tissues, not simply conventional genetic or immunologic markers, and to explore the application of emerging new technologies. The emphasis in these applications should be on discovery, rather than incremental improvements in existing strategies. This initiative envisions funding translational studies which identify promising new means for cancer diagnosis and which provide the initial, critical information necessary to decide whether potential clinical utility justifies further investment. This PA differs from the existing Program Announcement #PA-96-040 (Exploratory Grants for Correlative Laboratory Studies and Clinical Trials), which solicits applications for clinical trials of new cancer therapies and for correlative laboratory studies. PA-96-040 invites applications leading toward more effective cancer treatments or toward the identification of patient subsets for specific therapeutic strategies. This Program Announcement seeks to encourage projects at an even earlier stage of conceptual development. However, proposals must be based on a strong scientific rationale. Laboratory research should be clearly integrated with clinical goals, and should make use of human materials. Proposed projects should be designed to improve cancer diagnosis by translating basic research findings into new ways to examine human tissues. Where applicable, evidence of statistical support should be included to ensure proper correlation of laboratory measurements with clinical outcomes. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, Email: ASKNIH@od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The completed original application and five legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Center for Scientific Review, NIH in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? In this case, what is the potential for translation of basic research to clinical applications? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? This includes, where applicable, the statistical rationale for the study design and the choice of sample size. Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NCI. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Tracy G. Lugo Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard, Room 700, MSC 7388 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-1591 FAX: (301) 402-7819 Email: TL82S@NIH.GOV Direct inquiries regarding fiscal matters to: Joan Metcalfe Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-7800, extension 228 FAX: (301) 496-8601 Email: JM158R@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394. Awards are made 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 grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and part 92. 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 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.
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