FY98 CDMRP Status Report
SECTION I. EXECUTIVE SUMMARY
Background
In the past decade, heightened public awareness and increased interest in health issues have influenced scientific research. Cancer research has been a particular focus of attention due, in part, to the rising impact of cancer and the work of consumer advocacy organizations. In response to the concerns of the American population, the United States Congress has taken several actions, including directing the Department of Defense (DOD) to manage several appropriations totaling $916.6M as of fiscal year 1998 (FY 98), for intramural and extramural grant programs directed toward targeted research initiatives. The United States Army Medical Research and Materiel Command1 (USAMRMC) has been responsible for administering targeted appropriations made in FY 92-98 for research on breast cancer, prostate cancer, ovarian cancer, neurofibromatosis, defense women’s health, and osteoporosis. Together, these six programs are managed by the office of the Congressionally Directed Medical Research Programs2 (CDMRP), a scientific research area within the USAMRMC. This report has been prepared to address frequently asked questions about the CDMRP and its programs. The following topics are covered: program stewardship (Section II); program management, research products, and technology transfer (Section III); and summary information on all six CDMRP research programs (Sections IV-IX). The summaries of each program include Congressional directives, program execution, and research accomplishments (as applicable). Research accomplishments are reported primarily for FY 92-96. FY 97 awards were obligated by September 1998; most of these projects are currently in start-up phases. Program Announcements for the FY 98 appropriations have been released, proposals have been received, and proposal review is ongoing. Recently, Congress announced FY 99 appropriations for breast cancer, prostate cancer, ovarian cancer, and neurofibromatosis research. The CDMRP originated from a unique partnership among the public, Congress, and the DOD. Grass roots consumer advocate organizations provided much of the impetus that led to a FY 92 DOD appropriation of $25M targeted toward breast cancer research. In FY 93, in response to continuing public requests, Congress appropriated $210M in the DOD budget for extramural peer-reviewed breast cancer research. The U.S. Army was designated as the lead agent and the CDMRP was established. Congress has continued to appropriate funds for the DOD’s peer-reviewed Breast Cancer Research Program (BCRP). Starting in FY 95, the CDMRP has administered additional Congressionally directed peer-reviewed research programs which, as of November 1998, include the Defense Women’s Health Research Program, the Neurofibromatosis Research Program, the Osteoporosis Research Program, the Ovarian Cancer Research Program, and the Prostate Cancer Research Program (DWHRP, NFRP, ORP, OCRP, and PCRP, respectively). The CDMRP also oversees grants/contracts from other Congressional appropriations for specific intramural breast and prostate cancer research projects. To ensure the establishment of a scientifically sound program, in 1993 the DOD sought advice from the National Academy of Sciences’ Institute of Medicine (IOM) for the BCRP. The IOM recommended a two-tiered system of research proposal review (scientific/peer review and programmatic review, pgs. 24-25), which has been applied to all CDMRP peer-reviewed programs. The IOM also assessed the status of breast cancer research and recommended a broad-based investment strategy. At the initiation of the other programs, the CDMRP sponsored Stakeholders Meetings with expert panels representing scientific, clinical, and advocacy organizations. These panels provided information on important issues in their fields, which was utilized in the establishment of the new programs (pg. 23).1Known as the U.S. Army Medical Research and Development Command prior to 1995.
2Referred to as Research Area Directorate VI until 1997.
Partnerships
The unique public/private partnerships formed among the military, government, scientists, and consumer advocates affect multiple aspects of program execution. Since the FY 95 BCRP appropriation, consumer advocates (pgs. 25-26) have been involved in all levels of the process. Scientists and clinicians from diverse professional backgrounds working in the military, government, private sector, and academic environments have provided important insight to meet the needs of the research and advocacy communities. The partnerships formed between scientists and consumer advocates are important components in the development of investment strategies and the two-tiered review process (pgs. 24-25). The CDMRP Program Staff, a skilled, multidisciplinary team of military and civilian scientists and clinicians, lead by the CDMRP Research Area Manager and the Deputy Research Area Manager serves to coordinate the efforts of the CDMRP programs. Additionally, the office of the CDMRP utilizes support contractors for assistance in program management and evaluation, scientific and programmatic evaluation of research proposals, and management of funded research grants. (For additional information on these partnerships see pgs. 19-20.)Program Administration and Science Management
To accomplish the multiple program administration tasks, several established science management methods have been adapted and new innovations have been developed. For each appropriation, the CDMRP utilizes a flexible 6-year execution and management cycle to accommodate all stages from development of an investment strategy through the completion of research grants (pgs. 21-36). Each cycle is designated by the year of the appropriation and the name of the program, e.g., FY 95 BCRP. To establish an appropriate investment strategy that meets the current needs of both the research and consumer advocate communities, the Program Staff seeks the advice of expert panels (Integration Panels, pg. 24) composed of leaders in scientific and clinical research, and consumer advocates. Each program then utilizes a variety of award mechanisms to execute the investment strategy (pgs. 26-29). All programs have addressed community outreach, including the needs of under-served populations and recruitment of women and minorities (pgs. 12-18). Additionally, the office of the CDMRP has established several capacity building initiatives in infrastructure, training, and minority capacity building (pgs. 33-36). Information management, the maintenance of accurate and accessible program records as well as dissemination of research results, is another important component of the CDMRP. To address these needs, the CDMRP has employed a variety of research information management and dissemination methods (pgs. 30-32). Of particular note is the DOD BCRP Era of Hope conference that was held in the fall of 1997. This multidisciplinary meeting brought together over 1,100 scientists and consumer advocates to discuss recent developments in breast cancer research and announce the results from 543 DOD grants funded in the FY 92-95 BCRPs.Program-specific Information
Although the CDMRP programs share common management methods, each program is unique, with its own individually tailored goals and visions. These features allow the programs to meet the unique needs of their research and consumer advocate communities. Following are highlights of each program. The goal of the BCRP (Section IV) is to eradicate breast cancer. To meet this goal, the CDMRP has funded and manages a multidisciplinary research portfolio of over 1,400 prevention, detection, diagnosis, treatment, and quality of life studies from the $743.3M appropriated in FY 92-97. The research accomplishments are impressive and can be gauged, in part, by information reported in scientific peer-reviewed journals. In fact, over 1,250 publications on work accomplished with DOD funding have been self-reported by FY 92-96 awardees. The theme of the PCRP (Section V) is to support innovative ideas that can invigorate the field of prostate cancer research. Congress appropriated $45M in FY 97 and $40M in FY 98 for this program. In the first program cycle, 168 grants have been awarded or recommended for funding in five research categories: carcinogenesis, etiology, and tumor biology; special populations and behavioral patterns; genetics and molecular biology; and therapeutics and decreased morbidity. In addition 17 minority population focused grants and one Tri-Service project have been recommended for funding. The OCRP (Section VI) has been funded with $7.5M (FY 97) and $10M (FY 98) Congressional appropriations. The program vision is to support research aimed toward the prevention of ovarian cancer by providing grants for cancer centers and program projects. With the FY 97 appropriation, three research awards have been made to National Cancer Institute-designated Comprehensive Cancer Centers. For FY 98, the OCRP has solicited large Program Projects that will (1) advance ovarian cancer prevention strategies through enhanced understanding of ovarian cancer etiology, (2) engage experts from multiple disciplines in collaborative ovarian cancer research efforts, and (3) foster the development of a sustained national ovarian cancer research enterprise. The NFRP (Section VII) supports extramural research on the treatment and understanding of neurofibromatosis type I and II. NFRP appropriations have totaled $25.8M for FY 96-98. Fifteen awards were made with FY 96 and 97 appropriations for studies on the molecular biology, neural development, tumor biology, genetics, models, and natural history of tumor growth for these disorders. The focus of the FY 98 NFRP awards is investigator-initiated research with or without nested post-doctoral traineeships that will lead to clinical trials relevant to the disease and ultimately result in improved understanding, diagnosis, and treatment of neurofibromatosis. The DWHRP (Section VIII) was funded in FY 95 with a $40M Congressional appropriation.3 The DWHRP supported 69 intramural and extramural research projects. These projects addressed major factors affecting the health or work performance of military women, psychological and health issues resulting from the integration of women into a hierarchically organized male-dominated environment, health promotion and disease prevention, and access to and delivery of health care. The ORP (Section IX) was funded in FY 95 with a $5M Congressional appropriation for research on osteoporosis and bone-related diseases.3 The overall goal of the ORP is to support innovative basic and clinical research directed toward reducing the incidence of, decreasing the morbidity of, and improving the quality of life for patients with osteoporosis. In this program, five projects were funded that examine the role of genetics, growth factors, hormones, and other risk factors in osteoporosis.3The USAMRMC, but not the CDMRP, was also responsible for managing Congressional appropriations in 1992 for neurofibromatosis research, 1994 for Defense Women’s Health research, and 1997 for bone disease research.
Conclusion
The CDMRP supports research that will impact upon the health of all people by identifying gaps in funding and providing award opportunities that will satisfy research objectives without duplicating existing funding efforts. Through these efforts, this office has developed unique public/private partnerships to facilitate funding of quality research that addresses individual program objectives. The USAMRMC CDMRP will continue to develop these effective partnerships that may play a part in a comprehensive national health effort to benefit all peoples through scientific innovation and technology transfer.
