5
The Funded Portfolio of the 1993/1994 and 1995 BCRP Award Cycles

Since 1993 the Army's Breast Cancer Research Program (BCRP) has allocated almost $500 million to research, training, and infrastructure. In FY 1993/1994, Congress appropriated a total of $240 million for the program ($210 million for FY 1993 and $30 million for FY 1994), there were 2,641 grant submissions to the program, and 444 awards were made. The FY 1995 appropriation was $150 million and included two congressionally mandated programs: $20 million for mammography/breast imaging and $15 million for breast cancer centers. There were 2,209 FY 1995 grant proposals submitted and 287 awards made. For FY 1996 $75 million was appropriated for the BCRP, and $112.5 million has been allocated for FY 1997.

The first three sections of this chapter describe the portfolio of research funded by the BCRP during the FY 1993/1994 and FY 1995 award cycles. The final section examines how the portfolio of funded research compares to the research areas formulated and recommended by the 1993 IOM report.

RESEARCH PROJECTS

During the FY 1993/1994 funding cycle, the U.S. Army Medical Research and Development Command (later named the U.S. Army Medical Research and Materiel Command [USAMRMC]) followed closely the IOM 1993 report recommendations for the distribution of BCRP funds (IOM, 1993). Figure 5-1 compares the IOM's recommendation for the research projects by award mechanism with the actual distribution of awards for FY 1993/1994 and FY 1995. Of the total program expenditures of $218.8 million in FY 1993/1994,



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A Review of the Department of Defense's Program for Breast Cancer Research 5 The Funded Portfolio of the 1993/1994 and 1995 BCRP Award Cycles Since 1993 the Army's Breast Cancer Research Program (BCRP) has allocated almost $500 million to research, training, and infrastructure. In FY 1993/1994, Congress appropriated a total of $240 million for the program ($210 million for FY 1993 and $30 million for FY 1994), there were 2,641 grant submissions to the program, and 444 awards were made. The FY 1995 appropriation was $150 million and included two congressionally mandated programs: $20 million for mammography/breast imaging and $15 million for breast cancer centers. There were 2,209 FY 1995 grant proposals submitted and 287 awards made. For FY 1996 $75 million was appropriated for the BCRP, and $112.5 million has been allocated for FY 1997. The first three sections of this chapter describe the portfolio of research funded by the BCRP during the FY 1993/1994 and FY 1995 award cycles. The final section examines how the portfolio of funded research compares to the research areas formulated and recommended by the 1993 IOM report. RESEARCH PROJECTS During the FY 1993/1994 funding cycle, the U.S. Army Medical Research and Development Command (later named the U.S. Army Medical Research and Materiel Command [USAMRMC]) followed closely the IOM 1993 report recommendations for the distribution of BCRP funds (IOM, 1993). Figure 5-1 compares the IOM's recommendation for the research projects by award mechanism with the actual distribution of awards for FY 1993/1994 and FY 1995. Of the total program expenditures of $218.8 million in FY 1993/1994,

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A Review of the Department of Defense's Program for Breast Cancer Research FIGURE 5-1. Research projects by funding mechanism (amount in percentage). approximately 78% of the funds ($170.9 million) went to research projects and the remaining funds ($47.9 million) went for training and infrastructure enhancement. The funded research projects can be further subdivided into New Investigator Awards (NIAs) with 11.4% of the research funds, IDEA grants with 4.5% of the research funds, and more traditional Other Investigator-Initiated Awards (OIAs) garnering 84.1%. In FY 1995, of the $86 million specified for funding research projects a greater proportion was directed toward IDEA grants (12%) while a proportionately smaller amount was directed to more traditional OIA grants (76%). NIAs stayed constant with approximately 12% of research funds (USAMRMC, 1997). In FY 1996 the USAMRMC dramatically shifted funding toward IDEA awards. Of the $75 million total allocation in 1996, 53% was allocated for IDEA grants. This is over five times the amount awarded for IDEA grants in 1993/1994, and almost nine times more than originally recommended for this type of award by the IOM in 1993. NIAs and OIAs had been eliminated. During 1996, 20% of funds (approximately $15 million) were allocated for Research with Translational Potential (RTP) awards. These multidisciplinary projects should produce practical applications in prevention, detection, and

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A Review of the Department of Defense's Program for Breast Cancer Research treatment of breast cancer from new findings in genetics, cellular and molecular biology, and other basic science research areas. In FY 1993/1994, the distribution of awards by funding mechanism was proportional to the numbers of proposals received for each type of award. As shown in Figure 5-2, the proportion of research proposals receiving a scientific merit score of 2.9 or better (with a score of 1.0 indicating the highest scientific merit and a score of 5 indicating no merit) was approximately equal among funding mechanisms. A somewhat larger proportion of IDEA proposals scoring in the fundable range were recommended for awards. A greater proportion of the proposals received in 1995 were IDEA applications (33%) compared to 1993/1994 (20%) despite the fact that the BCRP was appropriated less money in 1995 than in 1993/1994 (see Figure 5-3). Similarly, a greater number of IDEAs were recommended for funding in 1995 (38%) compared to 1993/1994 (21%). IDEAs were favored over NIAs and OIAs in both cycles (Figures 5-2 and 5-3). It is particularly noteworthy that IDEA proposals as a group received the lowest percentages for merit scores of 2.9 or better but the highest percentages for award recommendations in both cycles. To meet programmatic goals, some proposals with relatively high technical merit scores were not recommended for funding, while some with lower technical merit scores were. The USAMRMC reported to the 1997 IOM FIGURE 5-2. Number of research proposals by funding mechanism, FY 1993/1994.

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A Review of the Department of Defense's Program for Breast Cancer Research FIGURE 5-3. Number of research proposals by funding mechanisms, 1995. committee, however, that the IP's funding priority recommendations were in agreement with those of the scientific review panels 90%–95% of the time (USAMRMC, 1997). Consistent with the 1993 IOM committee recommendations, the BCRP has funded a wide variety of research. The distribution of research projects by subject areas and disciplines for the 1993/1994 funding cycle is presented in Table 5-1. Among subject areas/disciplines, an approximately equal proportion of proposals received was ultimately recommended for awards, but health care delivery and epidemiology scored highest with 16% of applications recommended for funding. In the 1995 funding cycle the distribution of awards across subject areas and disciplines was similar to that in FY 1993/1994, except for radiology which included set-aside funds for mammography research (Table 5-2). A comparison of Tables 5-1 and 5-2 can be interpreted to show that as many or more proposals in underrepresented subject areas appear to have been received during the FY 1995 funding cycle as were received during the FY

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A Review of the Department of Defense's Program for Breast Cancer Research 1993/1994 funding cycle. Table 5-1, however, is not directly comparable to Table 5-2 because the former includes only research proposals, whereas the latter combines proposals for research and recruitment/training. Furthermore, some of the subject areas/disciplines used to sort proposals had changed from the FY 1993/1994 funding cycle to the FY 1995 cycle. Finally, during the 1995 funding cycle, the subject area/discipline of the proposal was designated by the investigator, whereas the subject areas/disciplines of proposals received during the FY 1993/1994 funding cycle were designated by the contractor, SAIC. INFRASTRUCTURE ENHANCEMENT The 1993 IOM report recommended that up to $21 million be allocated to enhance the infrastructure needed to carry out breast cancer research, and identified seven areas in which the BCRP funds could be used to shore up the research infrastructure. The 1993 IOM committee believed that these enhancements would help ensure that breast cancer researchers have access to the research tools they need. During the 1993/1994 funding cycle, the BCRP spent $23.3 million (11% of funds) on infrastructure enhancements, very nearly the amount recommended by the 1993 IOM committee. The allocations of funding among each type of infrastructure enhancement, however, were markedly different from what the IOM recommended (see Table 5-3). The BCRP awarded substantially less than what the IOM recommended for the development and enhancement of breast cancer registries, and substantially more for tissue banks and other shared resources. (Some of the tissue bank proposals recommended for funding also had registry components.) During the FY 1995 and FY 1996 funding cycles, no funds were set aside for infrastructure enhancements. The IP recommended against allocating any funds because relatively few scientifically meritorious infrastructure research proposals were received during the FY 1993/1994 funding cycle, and because the breast cancer infrastructure was perceived as currently solidly funded (USAMRMC, 1996c). TRAINING AND RECRUITMENT The BCRP has supported training at different levels (Table 5-4). The purpose of the training and recruitment awards is to bring new investigators into breast cancer research and to entice researchers from other fields to focus their efforts on breast cancer.

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 5-1. Distribution of Research Proposals by Subject Area or Discipline, Fiscal Year 1993/1994 Subject Area/Disciplinea No. of Proposals Received No. of Awards Recommended by IP Cell biology 475 60 (13%) Detection 354 26 (7%) Clinical sciences 157 15 (10%) Chemotherapy 183 10 (5%) Endocrinology 130 15 (12%) Epidemiology 151 24 (16%) Psychosocial sciences 120 16 (13%) Health care delivery 62 10 (16%) Immunology 127 17 (13%) Molecular biology 443 49 (11%) Total 2,202 242 (11%) a The 1993/1994 proposals were sorted into subject areas and disciplines by the Integration Panel contractor. SOURCE: USAMRMC, 1996c. TABLE 5-2. Distribution of Research and Recruitment/Training Proposals by Subject Area or Discipline, Fiscal Year 1995 Subject Area/Discipline No. of Proposals Received No. of Proposals Scoring 2.9 or Better No. of Awards Recommended by IPa Alternative medicine 5 4 (80%) 1 (20%) Behavioral/social sciences 106 51 (48%) 11 (10%) Cell biology 214 157 (73%) 31 (14%) Clinical/experimental therapeutics 333 224 (67%) 35 (11%) Endocrinology 184 122 (66%) 26 (14%) Epidemiology 148 87 (59%) 26 (18%) Health care delivery 62 39 (63%) 9 (15%) Immunological sciences 124 59 (48%) 7 (6%) Molecular biology 258 201 (78%) 40 (16%) Molecular genetics 147 98 (67%) 16 (11%) Pathobiology 257 150 (58%) 43 (17%) Radiation 182 90 (49%) 14 (8%) Radiological sciences 44 22 (50%) 9 (20%) Total Proposals 2,064 1,304 (63%) 268 (13%) a Proposals scoring 2.9 or higher. SOURCE: USAMRMC, 1996c.

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 5-3. Funding for Infrastructure Enhancement and Distribution of Proposals and Awards, Fiscal Year 1993/1994 Category 1993 IOM Recommendation ($million) 1993/1994 BCRP Funding ($million) No. of Proposals Received No. of Proposals Scoring 2.9 or Better No. of Awards Recommended by IPa,b Total funding ≤$21 $23.3 127 53 24 tissue banks 2 7.2 28 18 12 mouse husbandry 1 1.5 3 2 2 information systems 3 5.6 26 8 3 cancer registries 12 3.8 49 20 3 shared resources 3 5.2 21 5 4 a Proposals scoring 2.9 or better. b The Breast Cancer Research Program funded four infrastructure enhancement proposals with ratings above 2.9-two registries, one information system, and one shared resource. SOURCE: USAMRMC, 1996c.

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A Review of the Department of Defense's Program for Breast Cancer Research The 1993 IOM report recommended that up to $27 million be set aside for training and recruitment and divided among six training initiatives. The report further recommended that $4 million be allocated to fund up to 10 predoctoral training programs to bring together doctoral students from different disciplines with a common interest in breast cancer research. The committee also recommended that $3 million be spent on individual predoctoral fellowships to attract talented graduate students to breast cancer research and that $6 million be allocated for postdoctoral fellowships to allow fellows either to extend ongoing research related to breast cancer or broaden the scope of their research to include work relevant to breast cancer. During the 1993/1994 funding cycle, $19.7 million (9% of funds for awards) was awarded by the BCRP for training and recruitment. This included $4.8 million for predoctoral training programs, $2.1 million for predoctoral fellowships, and $6.5 million for postdoctoral fellowships. The IOM recommended that the BCRP allocate from $2.5 to $5 million for up to 50 ''instant sabbaticals" to allow mid-career investigators to receive training or explore new aspects of research relevant to breast cancer. However, only six sabbaticals were awarded, for a total of $570,000, because there were very few applications (USAMRMC, 1996c). BCRP management believed the lack of interest in the sabbaticals was a result of the timing of the announcement—late in the summer, after most academic faculty had finalized their plans for the upcoming academic year. Funding of $8 million was recommended (IOM, 1993) for up to 40 career development awards, to be given to junior faculty to conduct research relevant to breast cancer, and to allow them to accumulate the experience and data needed for them to compete for traditional research awards. During the 1993/1994 funding cycle, 34 career development awards were funded for a total of $5.7 million. The IOM (1993) also recommended that up to $1 million be set aside for interdisciplinary meetings to bring together investigators from different fields to discuss breast-cancer-related research. The IOM reasoned that such meetings would help foster interactions among investigators with diverse perspectives and expertise which could facilitate serendipitous collaborations and catalyze the development of creative and innovative approaches to breast cancer eradication. However, no money was allocated in FY 1993/1994 for interdisciplinary meetings; the IP reasoned that NIH and other agencies that fund breast cancer research provide sufficient funding for interdisciplinary meetings.

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 5-4. Funding for Training and Recruitment, Fiscal Year 1993/1994 Category 1993 IOM Recommendations 1993/1994 Funding Cycle 1995 Funding Cycle Predoctoral training programs 10 programs—$4 million 17 programs—$4.8 million ? programs—$122,000 Predoctoral fellowships Up to 50 fellows—$3 million 35 fellows—$2.1 million 36 fellows—$3.0 million Postdoctoral fellowships Up to 50 fellows—$6 million 49 fellows—$6.5 million 35 fellows—$4.1 million Special sabbaticals Up to 50 sabbaticals—$2.5 million-$5 million 6 sabbaticals—$570,000 No sabbaticals funded Career development awards Up to 40 awards—$8 million 34 awards—$5.7 million 18 awards—$3.5 million Interdisciplinary meetings Up to $1 million No meetings funded No meetings funded   SOURCE: IOM, 1993; USAMRMC, 1996c.

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A Review of the Department of Defense's Program for Breast Cancer Research The BCRP recommended a smaller proportion of predoctoral training program proposals with scientific merit scores in the fundable range for funding than it did other types of training and recruitment proposals, as evident from the data in Table 5-5. With regard to subject matter, the BCRP supported a broad portfolio of training and recruitment awards in FY 1993/1994 as recommended in the 1993 IOM report. Table 5-6 provides information about training and recruitment proposals received and the number of awards recommended by topic for funding during this funding cycle. Overall, 38% of training and recruitment grants were funded. The proportion of training and recruitment proposals in epidemiology, psychosocial sciences, and health care delivery significantly exceeded this proportion, with 13% of proposals received and 15% of the funded portfolio. On the other hand, cell and tissue biology, molecular biology, and immunology represented 65% of all training grants received and funded, while clinical and chemotherapy proposals were 9% of those received and 6% of those funded. Because of the small numbers of proposals received in certain areas, the IP recommended that, for FY 1995, special emphasis be directed toward increasing the number of training and recruitment proposals in the areas of psychosocial sciences, epidemiology, and clinical research. The 1995 BAA stated that up to $14.7 million of the $150 million appropriation for the BCRP would be allocated toward training and recruitment (USAMRMC, 1995b). Although the proportion of funds allocated for training remained nearly the same between FY 1993/1994 and FY 1995, the total amount declined in the 1995 funding cycle, commensurate with the reduced congressional allocation for the BCRP for FY 1995. The BCRP spent $10.8 million on training and recruitment, divided among individual predoctoral fellowships, postdoctoral fellowships, and career development awards (see Table 5-7). TABLE 5-5. Distribution of Proposals and Recommended Awards for Training and Recruitment, Fiscal Year 1993/1994 Category No. of Proposals No. of Proposals Scoring 2.9 or Better No. of Awards Recommended by IPa Total awards 349 199 (57%) 134 (38%) Predoctoral training programs 38 25 (66%) 11 (29%) Predoctoral fellowships 64 38 (59%) 29 (45%) Postdoctoral fellowships 142 86 (61%) 52 (37%) Special sabbaticals 19 8 (42%) 7 (37%) Career development awards 83 41 (49%) 35 (42%)   SOURCE: USAMRMC, 1996c.

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 5-6. Distribution of Training and Recruitment Awards Among Subject Areas/Disciplines, Fiscal Year 1993/1994 Subject Area/Disciplinea No. of Proposals Received No. of Awards Recommended by IPb Total training and recruitment awards 349 134 (38%) Cell and tissue biology 110 43 (39%) Detection 25 10 (49%) Clinical research 14 3 (21%) Chemotherapy 18 5 (28%) Endocrinology 19 4 (21%) Epidemiology 20 8 (40%) Psychosocial 18 7 (39%) Health care delivery 8 5 (63%) Immunology 16 6 (38%) Molecular biology 101 43 (43%) a For the 1993/1994 funding cycle, the subject area/disciplines represented by proposals were determined by the Science Applications International Corporation. b Proposals scoring 2.9 or better. SOURCE: USAMRMC, 1996c. TABLE 5-7. Distribution of Training and Recruitment Proposals by Funding Mechanisms, Fiscal Year 1995 Category No. of Proposals No. of Proposals Scoring 2.9 or Better No. of Awards Recommended by IP Total proposals 378 261 (69%) 99 (26%) Predoctoral fellowship 116 82 (71%) 41 (35%) Postdoctoral fellowship 149 105(70%) 39 (26%) Career development awards 113 74 (65%) 19 (17%)   SOURCE: USAMRMC, 1996c. Special sabbaticals were not offered during the 1995 funding cycle, in part because of the lack of sufficient proposals during 1993/1994 (USAMRMC, 1996c). No funds were allocated for new predoctoral training programs or interdisciplinary meetings in 1995, and predoctoral training programs were dropped because of their "questionable value" (USAMRMC, 1996c). By awarding funds directly to meritorious individuals rather than to institutional programs, the BCRP can more directly assess the individuals being recruited into the program.

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A Review of the Department of Defense's Program for Breast Cancer Research Breast Cancer Centers and Mammography/Breast Imaging Projects The 1995 appropriation included $20 million earmarked for mammography studies and $15 million earmarked for breast cancer centers (Committee on Appropriations, 1994b). The language accompanying the appropriation indicated that Congress was primarily interested in investing this money in studies of digital mammography (Committee on Appropriations, 1994a). However, the IP recommended that other types of breast cancer detection research also be considered for funding from the allocation. During the 1995 funding cycle, 70 mammography demonstration project proposals were received, of which 32 fell within the fundable range (scientific merit scores of 2.9 or better). Of these, 8 mammography demonstration projects were funded, for a total of $11.4 million. In addition, 6 OIAs and 8 IDEAs were recommended for funding from the set-aside mammography allocation at $4.2 million. The purpose of the mammography and breast imaging demonstration projects was to improve and verify the accuracy of breast imaging in institutional and community environments. Breast cancer center funds were directed toward developing patient-centered care in breast cancer centers and increasing access of breast cancer patients to clinical trials of new cancer therapies. In 1995, 11 proposals for breast cancer centers were received, of which 6 had scientific merit scores in the fundable range (scientific peer review score of 2.9 or better), and 3 breast cancer centers were funded for a total of $12.9 million. The small number of submitted proposals for breast cancer centers may have been a result of the requirement that the center be located at a single site. Historically Black Colleges and Universities/Minority Institutions To promote submissions from minority applicants, 5 percent of BCRP funds were set aside for historically black colleges and universities/minority institutions (HBCU/MIs) and small, disadvantaged businesses (SDBs), consistent with established U.S. Army policy (USAMRMC, 1996c). Nevertheless, proposals from HBCU/MIs and SDBs had to meet established standards for scientific acceptability or the set-aside would revert to the general funding pool. Table 5-8 outlines the number of proposals and awards for HBCU/MIs and SDBs. Opportunities for Minorities and Women The IOM (1993) recommended that the BCRP create opportunities for women and minorities who are traditionally underfunded. In the 1995 funding

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A Review of the Department of Defense's Program for Breast Cancer Research cycle there was a substantial increase of awards to minority principal investigators. The number of awards to female principal investigators also increased, despite an overall decrease in funds for the BCRP from the previous funding cycle. Proposals with female and/or minority principal investigators appear as likely or more likely to receive scores of 2.9 or better, and to be recommended for awards. Tables 5-9 and 5-10 outline the distribution of awards for minorities and women for FY 1993/1994 and FY 1995, respectively. FUNDING FOR PROGRAM ADMINISTRATION Funds for program administration cover review of scientific merit and program relevance; review of human use, animal use, and environmental/safety protocols; and up to four years of grant/contract performance monitoring (including site visits). During the 1993/1994 funding cycle, 7% of funds allocated to the BCRP went to management (USAMRMC, 1997); this was well below the target management budget of 10% of allocated funds. Just under 90% of administrative expenditures went to contractors providing peer review and programmatic support. About 4.6% of administrative expenses supported Army personnel and administration, and 5.5% were spent on maintenance, supplies, and equipment. TABLE 5-8. Numbers of HBCU/MI and SDB Proposals by Category of Award, Fiscal Year 1993/1994 Category of Awards No. of Proposals Received No. of Proposals Scoring 2.9 or Better (fundable range) No. of Proposals Funded Research (HBCU/MIs) 17 4 2 (both OIAs) Infrastructure (SDBs) 10 4 2 (1 tissue bank, 1 information system) Training and recruitment (HBCU/MIs) 3 1 1 (postdoctoral fellowship) NOTE: HBCU/MI = historically black colleges and universities/minority institutions; SDB = small, disadvantaged business; OIA = other investigator-initiated research. SOURCE: USAMRMC, 1996c.

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 5-9. Designation of Minority Status and Gender for Research Awards, Fiscal Year 1993/1994 Designationa No. of Proposals Received No. of Proposals Scoring 2.9 or Better No. of Proposals Recommended for Award Female investigator 96 95 (99%) 67 (70%) Minority investigator 38 36 (95%) 17 (48%) Female minority investigator 18 18 (100%) 16 (89%) a Designation of gender and minority status were optional items for inclusion on proposal submissions. SOURCE: USAMRMC, 1996c. TABLE 5-10. Designation of Minority Status and Gender, All Awards, Fiscal Year 1995 Designationa No. of Proposals Received No. of Proposals Scoring 2.9 or Better No. of Awards Recommended Female investigator 701 457 (65%) 110 (17%) Minority investigator 569 330 (58%) 64 (11%) Female minority investigator 178 113 (63%) 30 (17%) a The 1995 figures include both research proposals and training and recruitment proposals. Therefore, this table is not comparable with the table for FY 1993/1994. SOURCE: USAMRMC, 1996c. For the 1995 funding cycle, 5.9% of allocated funds went toward program management (USAMRMC, 1997). The proportion of program management expenses going to the peer review contractor decreased and the proportion going toward personnel and administration increased. The expense for the latter that year included the travel expenses for the members of the scientific peer review committees. The proportion of funds for maintenance, supplies, and equipment also decreased from the 1993/1994 funding cycle because most of the costs for purchasing equipment were incurred upon initiation of the program. DISTRIBUTION OF AWARDS AMONG RESEARCH AREAS Part of the USAMRMC's charge to IOM is to examine how the portfolio of research that was funded by the BCRP compares to the recommendations of the

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A Review of the Department of Defense's Program for Breast Cancer Research 1993 IOM committee as outlined in their report (1993). The 1993 IOM committee concluded that rather than targeting funds to specific disciplinary areas, the best way to ensure that the most promising research is funded is instead to create a framework for a broad portfolio of breast cancer research that would allow the best ideas to emerge from all disciplines (IOM, 1993). The 1993 IOM report identified six fundamental questions related to the causation, prevention, detection, diagnosis, and treatment of breast cancer, and recommended that research projects funded under the program be directed toward answering one or more of these questions. (The six fundamental questions are listed in Chapter 4.) The report also recommended that the funds not be restricted to proposals that deal solely or directly with breast cancer, but that funds be allocated to support the best proposals, as long as that work is relevant to at least one of the fundamental questions that the committee identified (IOM, 1993). The report noted that many of the discoveries that have benefited breast cancer patients have come about as a result of research that did not address breast cancer directly. In this spirit, the 1993 BAA stated that the six questions were intended to be "illustrative" of the types of research that would be funded under the program, and that "any promising research area that is relevant to breast cancer will be considered." A similar statement appeared in the overview section of the BCRP's 1995 BAA (USAMRMC, 1995b). It should be noted that the USAMRMC presented the IOM's fundamental questions in a slightly modified form. To ensure that men with breast cancer were not excluded from consideration, the language of the BAA was made gender-neutral. The fundamental question relating to epidemiology was reworded to include all types of epidemiological research—not only molecular epidemiology research, but also more traditional epidemiological research, including epidemiological studies to investigate the role of endogenous and exogenous risk factors in the development of breast cancer. To determine how well the BCRP portfolio was addressing the IOM-identified (1993) fundamental questions, the 1997 IOM committee examined the abstracts and award lists of projects recommended for funding in the 1993/1994 and 1995 cycles. Studies on genetic changes usually include research on the molecular and cellular consequences of these changes. Therefore, projects addressing questions 1 and 2 were combined in the analysis of the grants funded. A separate category for nonmolecular epidemiological studies was added (see Table 5-11). A portion of the BCRP allocation was congressionally earmarked for infrastructure development and mammography/breast imaging studies. The committee placed awards on mammography/breast imaging in a separate category (category M). The FY 1993/1994 funds allocated for infrastructure (i.e., tissue banks, mouse husbandry, information systems, registries, and shared

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A Review of the Department of Defense's Program for Breast Cancer Research resources) were also placed in a separate category (category I). The committee then assigned each of the research and recruitment/training grants recommended for funding during the FY 1993/1994 and FY 1995 award cycles to the research area to which it is primarily related (see Tables 5-12a,b and 5-13a,b). The committee constructed the tables based on awards lists made available by the Army that in turn were based on the IP recommendations for funding. The actual award amounts may differ slightly after the negotiations between the awarding unit and the investigators' institutions are completed. The committee found that the questions posed in the 1993 IOM report, as modified by the USAMRMC in the BAA, were sufficiently broad, and that all grants awarded during the FY 1993/1994 and FY 1995 funding cycles could be assigned to one of these categories (Tables 5-12a and 5-13a). In the 1993/1994 funding cycle, over half the funds ($120 million) were awarded for projects related to the basic genetic, cellular, and molecular research questions; less than 5% (about $10 million) was spent on studies to explain risk factors at the cellular and molecular level, and 3% went toward support of more standard epidemiological studies. In FY 1995, fewer dollars were directed toward basic research ($49 million) and epidemiological studies (over $4 million), but the amount awarded for studies of mechanisms of risk factors remained about the same as FY 1993/1994, despite a reduction in the congressional allocation for the BCRP program of almost 40 percent. Despite the lower levels of BCRP funds in FY 1995 (but reflective of the change in program priorities), nearly the same amount was spent in the 1995 funding cycle for research on breast cancer detection, diagnosis, and treatment—areas of high translational potential—as was spent in FY 1993/1994. Substantially more money was awarded to studies of mammography and other imaging techniques in the 1995 funding cycle compared to 1993/1994; this was a result of a special congressional set-aside of BCRP funds for digital mammography demonstration projects. Funding of studies relating to delivery of health services and psychosocial impact was at almost the same level in FY 1995 as in FY 1993/1994; in addition, three special breast cancer centers were funded in FY 1995. Conversely, during the 1995 funding cycle, there were no awards for predoctoral training programs or for enhancement of breast cancer research infrastructure.

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 5-11. Fundamental Areas of Breast Cancer Research Research Area Abbreviation Basic genetic, cellular, and molecular studies relevant to the origin and progression of breast cancer B (Basic) Risk factors, endogenous and exogenous: Studies of their molecular mechanisms R (Risk factors) Epidemiological studies of risk factors, progression, and outcome E (Epidemiology) Detection, diagnosis, prevention, treatment: Clinical studies (excluding imaging studies) D (Detection) Mammography: Studies of effectiveness and innovation in breast cancer imaging technology, including databases M (Mammography) Psychosocial: studies of psychosocial factors, quality of life, and clinical outcomes P (Psychosocial) Health care delivery: Studies of effectiveness and innovation in providing diagnosis, treatment, and followup care H (Health care delivery) Infrastructure: tissue or DNA banks, registries/databases regarding regional screening and outcome; establishment of cell lines and animal models I (Infrastructure) For both the 1993/1994 and 1995 funding cycles, the distribution of grants among research subject areas for NIAs, IDEA grants, and OIAs were similar, with the largest proportion of research grants directed toward investigations of genetic alterations and cellular and molecular changes in breast cancer. During the 1993/1994 funding cycle, most research awards were directed at the first of the five research areas—genetic alterations and cellular and molecular functions in breast cancer. This distribution mirrored the distribution of grant applications received, with the largest proportion in the areas of genetics and cellular and molecular biology (Tables 5-12a, b). During the 1995 funding cycle, the largest proportion of research awards and funding went into the same basic research area (Tables 5-13a, b), followed by research awards for translating findings in genetics and molecular and cellular biology into new methods of breast cancer prevention, detection, and treatment. The remainder of the funded research awards in FY 1993/1994 and FY 1995 appeared to be distributed approximately equally among the other important research subject areas identified by the IOM—that is, explorations of endogenous and exogenous risk factors and their relationship to processes occurring at the cellular and molecular level; studies of psychological, social,

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A Review of the Department of Defense's Program for Breast Cancer Research and cultural factors and their relationship to breast cancer prevention and treatment; and healthcare delivery and effectiveness research. In FY 1993/1994 research and training grants, only 3.8% of funded projects focused on minority and other traditionally underserved populations. However, in FY 1995, despite the reduced level of funding available, 9.6% of funded research proposals focused on underserved populations and concerned issues such as genetics, health care seeking behavior, health care delivery/access to care, health promotion and education, and epidemiology. Most of the funds for recruitment and training in FY 1993/1994 and FY 1995, like the research grants, were directed toward studies of genetic alterations and cellular and molecular functions in breast cancer. As discussed above, the six fundamental research questions, as originally formulated by the 1993 IOM committee, did not encompass standard or classical epidemiology. The 1993 IOM report emphasized the need for molecular epidemiology studies, that is, studies that related epidemiological findings to changes occurring at the genetic, molecular, and cellular levels. The IP recommended modifying the fundamental questions to include standard epidemiological research. For FY 1993/1994, there were 12 awards for epidemiology research and one training grant for classical epidemiological research (i.e., epidemiological research that was not cellular or molecular epidemiology [Table 5-12a]). For 1995, there were 14 research awards and two training grants related to classical epidemiological research (Table 5-13a).

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 5-12a. Number of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1993/1994   Funding Mechanisma,b Content OIA NIA IDEA CDA PTP PREF POST SS BANK HUSB INFO REG SHAR Total No. (%) Basic 120 24 26 25 3 29 36 2   1       266 (59.2%) Risk Factors 10 2 7 2     3             24 (5.4%) Epidemiology 9 1 2 2       1           15 (3.3%) Detection 21 4 7 2 1   2 1           38 (8.5%) Mammography 10 1 5 1   6 4       2   1 30 (6.7%) Psychosocial 9 1 3 2     1 1           17 (3.8%) Health Care Delivery 13 1 4       1 1     1     21 (4.7%) Infrastructure                 12 1 1 5 4 23 (5.1%) Training         13   2             15 (3.3%) TOTAL 192 34 54 34 17 35 49 6 12 2 4 5 5 449   42.8% 7.6% 12.0% 7.6% 13.8% 7.8% 10.9% 1.3% 2.7% 0.5% 0.9% 1.1% 1.1%   a OIA = Other Investigator-Initiated Awards; NIA = New Investigator Awards; IDEA = Innovative DEvelopmental and Exploratory Awards, CDA = Career Development Awards; PTP = Predoctoral Training Programs; PREF = Predoctoral Fellowships; POST = Postdoctoral F SS = Special Sabbaticals; BANK = Tumor Sample, Breast Tissue, and Cell Line Repositories; HUSB = Transgenic Mouse Husbandry; INFO = Information Systems; REG = Enhancement of Existing Cancer Registries; New Registries of High Risk Individuals; SHAR = Other Innovative Shared Resources. b Five awards were split into two separate awards because they had been assigned two funding mechanisms by the Army: four OIA/CDA and one NIA/CDA were split into four OIA, one NIA, and five CDA awards. SOURCE: USAMRMC, 1995a, 1995d.

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 5-12b. Amounts of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1993/1994 ($ millions)   Funding Mechanisma,b Content OIA NIA IDEA CDA PTP PREF POST SS BANK HUSB INFO REG SHAR Total No. (%)c Basic 91.7 13.3 3.8 4.9 0.19 1.8 4.1 0.19   0.51       120.5 (56.5%) Risk Factors 7.6 0.68 0.89 0.36     0.36             9.9 (4.7%) Epidemiology 5.0 0.62 0.30 0.39       0.10           6.4 (3.0%) Detection 15.0 2.2 1.0 0.40 0.02   0.30 0.10           19.1 (9.0%) Mammography 6.1 0.59 0.75 0.20   0.35 0.54       2.1   1.2 11.8 (5.5%) Psychosocial 7.8 0.60 0.44 0.40     0.08 0.09           9.4 (4.4%) Health Care 9.7 0.60 0.58       0.14 0.09     0.70     11.8 (5.5%) Delivery                             Infrastructure                 7.2 1.0 2.8 3.7 4.1 18.8 (8.8%) Training         4.6   0.94             5.5 (2.6%) TOTAL 142.8 18.6 7.8 6.7 4.8 2.2 6.4 0.6 7.2 1.5 5.6 3.7 5.2 213.2   67.0% 8.74% 3.6% 3.1% 2.3% 1.0% 3.0% 0.3% 3.4% 0.7% 2.6% 1.8% 2.5%   a OIA = Other Investigator-Initiated Awards; NIA = New Investigator Awards; IDEA = Innovative Developmental and Exploratory Awards; CDA = Career Development Awards; PTP = Predoctoral Training Programs; PREF = Predoctoral Fellowships; POST = Postdoctoral F SS = Special Sabbaticals; BANK = Tumor Sample, Breast Tissue, and Cell Line Repositories; HUSB = Transgenic Mouse Husbandry; INFO = Information Systems; REG = Enhancement of Existing Cancer Registries; New Registries of High Risk Individuals; SHAR = Other b Five awards were split into two separate awards because they had been assigned two funding mechanisms by the Army: four OIA/CDA and one NIA/CDA were split into four OIA, one NIA, and five CDA awards. SOURCE: USAMRMC, 1995a, 1995d.

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 5-13a. Number of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1995a   Funding Mechanismb Content OIA NIA IDEA CDA PREF POST DEMO Total Basic 43 10 35 11 26 28   153 (52.9%) Risk Factors 8 4 8   3 4   27 (9.3%) Epidemiology 4 1 5 3   1   14 (4.8%) Detection 17 2 8 2 2 1   32 (11.1%) Mammography 10   12 1 1 1 8 33 (11.4%) Psychosocial 7   1   2     10 (3.5%) Health Care 9 2 6 1 2     20 (6.9%) Delivery                 Total 98 19 75 18 36 35 8 289   33.9% 6.6% 25.9% 6.2% 12.5% 12.1% 2.8% 100% a The three funded cancer centers are not included in this table. b OIA = Other Investigator-Initiated Awards; NIA = New Investigator Awards; IDEA = Innovative Developmental Exploratory Awards; CDA = Career Development Awards; PREF = Predoctoral Fellowships; POST = Postdoctoral Fellowships; DEMO = Demonstration Projects. SOURCE: USAMRMC, 1996b, 1996d. TABLE 5-13b. Amounts of Funded Grants, U.S. Army Breast Cancer Research Program, Fiscal Year 1995a   Funding Mechanismb ($ millions) Content OIA NIA IDEA CDA PREF POST DEMO Total Basic 29.9 5.5 5.9 2.1 2.4 3.3   49.1 (43.8%) Risk Factors 6.1 2.1 1.2   0.18 0.48   10.0 (8.9%) Epidemiology 3.1 0.06 0.74 0.60   0.08   4.6 (4.1%) Detection 10.7 1.2 1.1 0.41 0.14 0.15   13.7 (12.2%) Mammography 7.5   1.7 0.20 0.05 0.12 11.4 21.0 (18.7%) Psychosocial 5.2   0.15   0.13     5.4 (4.8%) Health Care 5.6 1.2 0.82 0.60 0.14     8.4 (7.5%) Delivery                 Total 68.0 10.0 11.6 3.9 3.0 4.1 11.4 112.1c   60.7% 8.9% 10.4% 3.5% 2.7% 3.7% 10.2%   a The three funded cancer centers are not included in this table. b OIA = Other Investigator-Initiated Awards; NIA = New Investigator Awards; IDEA = Innovative Developmental Exploratory Awards; CDA = Career Development Awards; PREF = Predoctoral Fellowships; POST = Postdoctoral Fellowships; DEMO = Demonstration Projects. c May not add to 100% because of rounding. SOURCE: USAMRMC, 1996b, 1996d.