1
Introduction

THE ARMY BREAST CANCER RESEARCH PROGRAM

In 1991 Congress appropriated $25 million for breast cancer research in the Army's Research, Development, Test, and Evaluation Program for the purpose of pursuing interservice research on breast cancer screening and diagnosis for military women and dependents of military men. This appropriation was contained in the Defense Appropriations Act for fiscal year (FY) 1992 (Public Law 102-172). It marked the beginning of the Army's Breast Cancer Research Program (BCRP). In FY 1993, Congress included $210 million in the Defense Appropriations Act to support a peer-reviewed breast cancer research program (Public Law 102-396). This appropriation was largely the result of successful lobbying efforts by the National Breast Cancer Coalition (NBCC). The Army subsequently assigned these funds to its Medical Research and Development Command (now known as the U.S. Army Medical Research and Materiel Command [USAMRMC]), which continues to administer the BCRP.

Because the FY 1993 appropriation represented a nearly 10-fold increase in funds for the breast cancer program, and because Congress stipulated that the research funded must be externally peer-reviewed, the Army sponsored a study by the Institute of Medicine (IOM) to elicit advice and recommendations regarding programmatic investment strategies and scientific peer review. This effort resulted in the 1993 IOM report Strategies for Managing the Breast Cancer Research Program: A Report to the U.S. Army Medical Research and Development Command. The 1993 IOM report recommended a program designed to advance breast cancer research by nurturing new avenues of



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A Review of the Department of Defense's Program for Breast Cancer Research 1 Introduction THE ARMY BREAST CANCER RESEARCH PROGRAM In 1991 Congress appropriated $25 million for breast cancer research in the Army's Research, Development, Test, and Evaluation Program for the purpose of pursuing interservice research on breast cancer screening and diagnosis for military women and dependents of military men. This appropriation was contained in the Defense Appropriations Act for fiscal year (FY) 1992 (Public Law 102-172). It marked the beginning of the Army's Breast Cancer Research Program (BCRP). In FY 1993, Congress included $210 million in the Defense Appropriations Act to support a peer-reviewed breast cancer research program (Public Law 102-396). This appropriation was largely the result of successful lobbying efforts by the National Breast Cancer Coalition (NBCC). The Army subsequently assigned these funds to its Medical Research and Development Command (now known as the U.S. Army Medical Research and Materiel Command [USAMRMC]), which continues to administer the BCRP. Because the FY 1993 appropriation represented a nearly 10-fold increase in funds for the breast cancer program, and because Congress stipulated that the research funded must be externally peer-reviewed, the Army sponsored a study by the Institute of Medicine (IOM) to elicit advice and recommendations regarding programmatic investment strategies and scientific peer review. This effort resulted in the 1993 IOM report Strategies for Managing the Breast Cancer Research Program: A Report to the U.S. Army Medical Research and Development Command. The 1993 IOM report recommended a program designed to advance breast cancer research by nurturing new avenues of

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A Review of the Department of Defense's Program for Breast Cancer Research investigation and attracting new investigators into the field. It recommended a three-pronged programmatic investment strategy to support scientific initiatives in the following areas: scientist training and recruitment: $27 million, infrastructure enhancement: $21 million, and investigator-initiated research: $151.5 million. The report (IOM, 1993) also recommended that the BCRP institute a two-tiered system of peer review for research proposals submitted to the program. The first tier would be responsible for assessing the scientific excellence of the research proposals and the second tier would award funding based on their programmatic relevance. The report emphasized the importance of "channeling the research funds in directions that stimulate innovative ideas, involve interdisciplinary research, enhance the use of existing research resources, and reward scientific excellence among all disciplines" (IOM, 1993). Congress appropriated another $30 million for the BCRP in FY 1994 (Public Law 103-139), $150 million in FY 1995 (Public Law 103-335), and $75 million in FY 1996 (Public Law 104-61), for a total of $465 million. While some of these funds have been congressionally directed toward specific areas (e.g., breast cancer centers, digital mammography technology and automated mammography screening, increased access to care, and improved treatment for military members and their dependents), the vast majority of funds were designated to support peer-reviewed scientific research focusing on the causes, prevention, detection, treatment, and outcome of breast cancer. CHARGE TO THE 1997 IOM COMMITTEE In late 1995, the USAMRMC asked the IOM to review the implementation and progress of the BCRP. Specifically, the IOM was asked to: (1) review the portfolio of breast cancer research funded by the Army's BCRP as well as breast cancer research supported by other public and private funding agencies; (2) provide an analysis of the BCRP as it has been implemented in response to the 1993 IOM report recommendations, assessing the process employed in program management and program achievement; and (3) provide recommendations delineating important research areas for which current support and programs are not yet in place or in which additional emphasis is needed.

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A Review of the Department of Defense's Program for Breast Cancer Research RESOURCES AND METHODS USED FOR THIS REPORT To accomplish these tasks, the IOM, in 1996, assembled an independent group of 13 individuals who represented a broad range of disciplines—basic, clinical, and public health research; surgical, radiation, and medical oncology; genetics; sociology; epidemiology; nursing; obstetrics and gynecology; health services research; health administration; and law. One member was also a breast cancer survivor with formal ties to a breast cancer advocacy group. The committee met five times during a 7-month period. The committee based its analysis and subsequent deliberations on reviews of BCRP documents; interviews with the BCRP director and key staff, BCRP contractors, and scientific advisors to the program; and the testimony of BCRP consumer participants, representatives of other breast cancer research funding agencies, and advocacy group representatives. The IOM committee reviewed the Broad Agency Announcements (BAAs) that were used to solicit BCRP research proposals, BCRP application forms, the abstracts and titles of proposals funded by the program in FY 1993/1994 and FY 1995, reports of funding allocations and program expenditures, and documents detailing the role of other Army agencies involved in the proposal review and contracting process, including those involved in the use of human subjects and animals, environmental safety, and regulatory compliance. The IOM committee also heard testimony and reviewed documents from the two main BCRP contractors: United Information Systems Inc. (UIS), which provides management of the first-tier peer review system, and Science Applications International Corporation (SAIC), the administrative support contractor to the BCRP director. The committee obtained detailed information on the peer review system including mechanisms for recruiting executive secretaries and scientific peer review chairs and panelists, the frequency distributions of technical merit scores assigned to proposals (classified by peer review panel and award category), funding recommendations and review summaries as well as records of deliberations of the Integration Panel (IP). In addition, the committee reviewed the legislative language directing the program. It was too early in the BCRP's history to obtain progress reports for the research projects it had already funded, although comments on the BCRP application and annual review process were obtained from almost 100 grantees through a "Dear Colleague" letter to all grant recipients. The committee contacted several organizations to solicit presentations and written materials regarding each program's mechanisms for establishing funding priorities, problems experienced in the scientific peer review, and methods used, if any, to solicit consumer participation in funding decisions. Funding agencies were asked to describe their research program initiatives, subjective assessments of the success of existing breast cancer research programs, and their plans for

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A Review of the Department of Defense's Program for Breast Cancer Research future breast cancer research funding. Groups providing information to the committee are listed in Box 1-1. The committee heard the testimony of representatives from the National Institutes of Health's (NIH) Division of Research Grants and Office of Extramural Affairs, the National Science Foundation (NSF), and three of the executive secretaries who previously conducted scientific peer reviews at the BOX 1-1. Groups Providing Input to the 1997 Institute of Medicine Breast Cancer Research Committee Department of Defense/Contractors USAMRMC-BCRP staff United Information Systems, Inc. • Management team • Executive secretaries Science Applications International Corporation • Management team • Integration panel members U.S. Army Regulatory Compliance and Quality Office Major Breast Cancer Funding Institutions National Institutes of Health, National Cancer Institute Susan G. Komen Foundation American Cancer Society Peer Review Specialists National Institutes of Health, Division of Research Grants National Institutes of Health, Office of Extramural Affairs National Science Foundation Professional Societies American Society for Clinical Nutrition (letter) American Society of Clinical Oncology (letter) Consumer Organizations/Advocacy Groups Minority Women with Breast Cancer Uniting, Inc. National Breast Cancer Coalition Arm-in-Arm California Breast Cancer Coalition Women in Touch Breast Cancer Network (letter) Virginia Breast Cancer Foundation (letter) National Asian Women's Health Organization (letter)

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A Review of the Department of Defense's Program for Breast Cancer Research NIH, NSF, and for the BCRP. The committee held discussions with past and present chairs and members of the Integration Panel regarding programmatic review processes and program policy decisions. Staff members, under committee guidance, conducted an extensive literature search of various databases to attain a more "global" view of the topics currently being studied in breast cancer research and to delineate important areas in which programs are not in place or which would benefit from additional emphasis. Databases searched included Medline, Defense Technical Information Center (DTIC), Defense Research On-Line System (DROLS), the National Institutes of Health's Computer Retrieval of Information on Scientific Projects (CRISP), Federal Research in Progress (FedRIP), the GRANTS database for philanthropic organizations, and the Research and Development in the United States (RaDiUS) database developed by the Critical Technologies Institute at RAND. Finally, the committee elicited written comments regarding the BCRP from FY 1993/1994 and FY 1995 grant recipients who responded to the committee's "Dear Colleague" mailing (see Appendix C and D). This effort was aimed at learning about investigators' experiences applying for and obtaining funds from the BCRP. Government confidentiality regulations precluded surveying all applicants (funded and unfunded). This range of activities provided the committee with a wealth of diverse information on which to base its deliberations. (The information collected is described in more detail in the appendixes.) This report presents the results of the committee's analyses and deliberations, its conclusions, and its recommendations. Chapter 1 provides the background for the study and the committee's charge, Chapter 2 focuses on breast cancer biology and medicine, Chapter 3 reviews non-BCRP support of breast cancer research, Chapter 4 focuses on the BCRP program, Chapter 5 discusses the funded portfolio of the FY 1993/1994 and FY 1995 BCRP award cycles, Chapter 6 provides the program critique, and Chapter 7 gives the committee's conclusions and recommendations.