PA-02-005: ECONOMIC STUDIES IN CANCER PREVENTION, SCREENING AND CARE

Department of Health
and Human Services (HHS)

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This Program Announcement expires on October 2, 2003, unless reissued. ECONOMIC STUDIES IN CANCER PREVENTION, SCREENING AND CARE Release Date: October 4, 2001 PA NUMBER: PA-02-005 (see replacement PA-04-017) National Cancer Institute (NCI) Agency for Healthcare Research and Quality (AHRQ) This Program Announcement (PA) replaces PA-99-014, which was published in the NIH Guide on November 12, 1998. THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. Since AHRQ study sections requires complete budget information in their review, all applications assigned, after initial submission, to AHRQ for review and funding considerations will be requested to submit detailed budget pages prior to the study section review. PURPOSE The Division of Cancer Control and Population Sciences (DCCPS), National Cancer Institute (NCI) and the Agency for Health Care Research and Quality (AHRQ), invite investigator-initiated grant applications for research directed at increasing the knowledge base in the area of the economic aspects of cancer prevention, screening and care. The goal of this program announcement is to generate new economic knowledge that will promote the optimal design of cancer prevention and control trial studies and interventions and will facilitate the formulation of effective health care policy related to cancer prevention and control. NCI has an interest in economic and health services studies with particular emphasis on meeting the goals of the NCI Quality of Cancer Care Initiative (http://plan2002.cancer.gov/infquality.htm). The overall goal of this Initiative is to enhance the state of the science on the quality of cancer care and inform federal decision making on care delivery, coverage, and regulation.. This initiative requests research applications on new methods development, the synthesis and extension of existing methods, and innovative data gathering strategies. Applications that propose to implement actual data collection on a pilot or full-scale basis as well as analytical studies that use existing data and methodology may also be submitted. This Program Announcement (PA) relates to the general health services and outcomes and effectiveness research supported by the AHRQ for a wide range of clinical conditions, including cancer. For example, AHRQ is presently supporting research that supports improvements in health outcomes, strengthens quality measurement and improvement, identifies strategies to improve access, foster appropriate use, and reduce unnecessary expenditures, and methodologic advances in health services research, especially cost-effectiveness analysis. Related research priorities are described in AHRQ Health Services Research Program Announcement PA-00-111, which is available on the WEB at: http://grants.nih.gov/grants/guide/pa-files/PA-00-111.html RESEARCH OBJECTIVES Background There is increasing interest in the collection and analysis of valid, accurate and reliable economic data related to specific disease entities and preventive, screening and treatment intervention related to specific disease entities. For example, the 1998 Institute of Medicine report on Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the NIH (see http://www.nap.edu/readingroom/books/nih/) recommends that, "In setting priorities, NIH should strengthen its analysis and use of health data, such as burdens and costs of diseases, and of data on the impact of research on the health of the public." The DHHS panel on cost effectiveness in health and medicine (As summarized in Gold MR, et al. Cost Effectiveness in Health and Medicine. Oxford University Press, 1996) recognized that for purposes of health care program and policy evaluation economic data on diseases and health care interventions must go beyond the type of aggregate data needed for cost of disease studies to include longitudinal data on direct medical costs as well as data on time and productivity costs related to diseases and health care interventions. Scope of Activity This initiative supports research directed at increasing our understanding of economic aspects of cancer prevention, screening and care. Cancer is a heterogeneous chronic disease characterized by innovation in treatment and care approaches. Studies that cover the national population of all ages on an episodic basis fail to capture an adequate sample of cancer patients or the full scope and duration of cancer costs. Studies that focus on a convenience sample of cancer patients in a single health care delivery setting or community can be criticized as lacking external validity. Studies proposed in response to this PA will be expected to address these issues and propose innovative methods of overcoming these limitations. Examples of research topics that would be considered relevant to meeting the goals of this PA include: 1. The economic burden to the individual cancer patient, family and society resulting from cancer and cancer treatment, including time costs, reduced employment opportunities and reduced access to health and life insurance. 2. Economic factors at the individual, community and health system level that effect access to and outcomes following the use of cancer-related prevention, screening, diagnostic and treatment services. 3. The cost and organizational structure of delivering cancer prevention, screening and treatment services in relation to various health care delivery settings and health care market structure conditions. 4. Cost-utility, cost-effectiveness or cost-benefit of specific cancer prevention and screening trials and cancer prevention and control interventions. 5. The interaction of cost, cost-effectiveness and other factors in decision making process related to the provision and delivery of cancer prevention, screening and treatment at the physician-patient, health system and health policy levels. 6. The role of economic factors and financial incentives in determining the level of participation of patients, physicians and health care delivery systems in cancer prevention, screening and treatment clinical trials. 7. The identification, development and validation of data resources needed to support relevant and generalizable economic evaluation studies related to cancer prevention, screening and treatment. 8. Methodological studies on the measurement, evaluation and presentation of data on cost and cost-utility/effectiveness/benefit in relation to cancer specific issues. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) research project grant (R01) or an exploratory/developmental grant (R21). Applicants will be responsible for planning, direction and execution of the proposed project. Awards will be administered under NIH grants policy as stated in the NIH Policy Statement. The total project period for an application submitted in response to this PA may not exceed 5 years for an R01 application and 2 years for an R21 application. Applicants without extensive preliminary data or who wish to explore the utility of claims-based data to address a specific question are urged to submit applications for this PA using the exploratory/developmental grant mechanism. Investigators are encouraged to seek continued support after completing an exploratory/ developmental grant project through a research project grant (R01). Specific application instructions have been modified to reflect "MODULAR GRANT" and JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at: http://grants.nih.gov/grants/funding/modular/modular.htm. For R21 submissions, applicants may request up to $100,000 direct costs (four budget modules) per year unless the application includes consortium costs, in which case the limit is $125,000 direct costs (five budget modules) per year. 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. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Martin Brown, Ph.D. Applied Research Branch Division of Cancer Control and Population Sciences National Cancer Institute Executive Plaza North, Room 4005 Bethesda, MD 20892-7344 Telephone: (301) 496-5716 FAX: (301) 435-3710 Email: mb53o@nih.gov Yen-pin Chiang, Ph.D. Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 6010 Executive Boulevard, Suite 300 Rockville, MD 20852 Telephone: (301) 594-4035 FAX: (301) 594-3211 Email: ychiang@ahrq.gov Direct inquiries regarding fiscal matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South - 243 Bethesda, MD 20892 Telephone: (301) 496-8634 FAX: (301) 496-4801 Email: wolfreyc@mail.nih.gov Mabel Lam Agency for Health Care Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447 X1165 APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Beginning January 10, 2002, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (Type 1), competing continuation (Type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the NCI program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the NCI staff that the NCI will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. The title and number of the program announcement 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 five signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned based on established NIH referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. 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? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches, or methods? 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: o the appropriateness of proposed project budget and duration, o the adequacy of plans to include both genders, minorities (and their subgroups), and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, o the provisions for the protection of human and animal subjects, o the safety of the research environment, o the adequacy of the proposed plan to share data. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. 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 sub- populations 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 indicating 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups, if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html 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. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the NIH policy on education in the protection of human research participants now required for all investigators, which is published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is now available online at http://cme.nci.nih.gov/. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. REQUIREMENTS FOR SHARING RESEARCH RESOURCES NIH policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community when they have been published. All investigators should read the Guidelines available at the following url address: http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm. See also: NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps) and Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts: Final Notice, December 1999 (http://www.nih.gov/od/ott/RTguide_final.htm). It is expected that biomaterials and other patentable research resources (examples could be, but are not limited to, vectors, embryonic cell lines, mutant mice, etc.) produced in projects funded by this initiative will be made available and distributed to the broader scientific community. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This PA, Economic Studies in Cancer Prevention, Screening and Care, is related to priority area of cancer control. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research, 93.121, Oral Health Research and 93.226. 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 67, Subpart A, 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 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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