Strategies to Leverage Research Funding Guiding DOD's Peer Reviewed Medical Research Programs (2004) / Chapter Skim
Currently Skimming:
1 Introduction
1 Introduction
Pages 13-36
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 13... ...
At the same time, concern about breast cancer specifically was being mobilized by a new grassroots organization, the National Breast Cancer Coalition 13
|
From page 14... ...
As a result, many members of the cancer research and advocacy communities, spearheaded by NBCC, worked with Congress to identify a source of new funds for breast cancer research that would not further reduce the funding for existing cancer research programs. One attractive source of funding at that time was DOD, which had approximately $29 billion in unobligated funds from prior years for the development of weapons systems planned before collapse of the Soviet Union in 1991.1 Those funds were put off limits by the Budget Enforcement Act of 1990, which established "firewalls" between the budgets for defense, foreign affairs, and domestic programs and imposed strict caps on funding increases in each of the three categories.
|
From page 15... ...
The next day, Senator Alphonse D'Amato offered an amendment specifically to transfer $214 million for breast cancer research from DOD to NIH, which was defeated 53-43 (Congressional Record, September 17, 1992, p.
|
From page 16... ...
These scientists were not required to have the preliminary data that would be required by traditional individual investigator awards. The report recommended that the Army program use a two-tiered review system, in which the first tier would consist of peer review of scientific merit conducted by study sections (i.e., expert panels)
|
From page 17... ...
It is not duplicative of other programs and is a promising vehicle for forging new ideas and scientific breakthroughs in the nation's fight against breast cancer. The 1997 IOM committee identified a number of outstanding program features, including the flexibility of the annual priority setting process; the use of outside peer reviewers to evaluate proposals; the involvement of consumer advocates in the peer review process; and low administrative costs.
|
From page 18... ...
The most notable is probably the identification and understanding of antagonists to the overexpression of the HER2 gene, which led to the development of Herceptin, a breast cancer therapeutic agent based on an anti-HER2 antibody (CDMRP, 1999:Section 5)
|
From page 19... ...
~140 ~35 ~6 6 SOURCE: CDMRP, 2003. years earlier with funding from the National Cancer Institute and Revlon, but researchers still lacked a regular source of breast tissue from women with breast cancer, women who were high risk (from biopsies)
|
From page 20... ...
, in consultation with the service Surgeons General and the Institute of Medicine, to investigate alternative funding sources, including private sector and non-Federal contributions that can best be used to leverage appropriated funds without biasing the peer review selection process." In response, the IOM Committee on Alternative Funding Strategies for DOD's Peer Reviewed Biomedical Research Program was established to assess current and alternate funding mechanisms and funding sources, which include private sector and other nonfederal entities, for conducting biomedical research. Specifically, the committee was asked to carry out the following tasks: 1.
|
From page 21... ...
Current examples of CSI programs include Military Human Immunodeficiency Virus Research; Surgical Tissue Replacement and Repair; the Neurotoxin Exposure Treatment Program; the Osteoporosis and Bone Health Research Program; Epidermolysis Bullosa Research; and the Center for Innovative Minimally Invasive Therapy. Partnerships: Consumers, the Scientific Community, and the Military Most notably, CDMRP has been a pioneer in its work in consumer involvement in scientific priority setting (Rich et al., 1998)
|
From page 22... ...
The Ovarian Cancer Research Program meeting, for example, would include representatives of pharmaceutical companies, biotechnology companies, different advocacy groups, NCI, and others who fund ovarian cancer research. These groups also help CDMRP programs establish their initial Integration Panels.
|
From page 23... ...
It is responsive to real need." Advocates also support the program's strategy of fostering innovation by supporting novel ideas and new investigators. At the time of the establishment of BCRP, the original program, advocates for breast cancer research saw the program as a way to support new ideas about the causes of disease that could be translated into new treatments, instead of supporting research to extend and refine ideas that have been proven, which NIH was already doing with far greater resources (Marshall, 1993)
|
From page 24... ...
24 4.3 3.0 0 85.0 20.0 10.0 50.0 FY04 150.0 322.3 4.3 2.0 0 85.0 20.0 10.0 50.0 FY03 152.2 323.5 5.0 1.0 85.0 21.0 10.2 50.0 42.5 FY02 151.5 366.2 17.0 12.0 50.0 FY01 177.4 100.0 356.4 75.0 15.0 12.0 25.0 FY00 176.3 303.3 50.0 11.5 10.0 19.5 FY99 136.8 227.8 9.8 40.0 10.0 FY98 135.0 194.8 dollars) of 8.0 7.5 45.0 FY97 108.3 168.8 8.0 millions FY96 75.0 83.0 (in FY95 150.0 150.0 Programs FY94 30.0 30.0 Core FY93 210.0 210.0 CDMRP FY92 25.0 25.0 of History CDMRP.
|
From page 25... ...
CDMRP Programs Since its inception, CDMRP has managed 29 separate programs, 8 of which are considered core programs. Core programs have either received or have the
|
From page 26... ...
BOX 1-1 CDMRP Core Programs The Breast Cancer Research Program (BCRP) is the second largest funder of extramural breast cancer research in the world, having managed approximately $1.52 billion in appropriations from FY 1992 to FY 2003.
|
From page 27... ...
Ann Kolker, Ovarian Cancer National Alliance, noted at the April workshop that this federal investment is significant given the scarcity of funds in the private sector, stating that, "given the very, very small amount of privately raised funds available for ovarian cancer research, it is frankly completely unrealistic to expect that charitable foundations and similar organizations could augment in any signif icant way the investment made by the Federal Government in ovarian cancer research." The Peer Reviewed Medical Research Programs (PRMRPs) supports research on issues with direct relevance to military health.
|
From page 28... ...
The investment strategy provides the framework and direction necessary to most effectively obligate each congressional appropriation, while avoiding unnecessary duplication with other funding agencies. Award Mechanisms A critical component of the CDMRP investment strategy is the development of specific award mechanisms that capture the current needs of both the research and advocacy communities.
|
From page 29... ...
, while other mechanisms support clinical research exclusively (e.g., Clinical Translational Research Awards and Clinical Trial Awards)
|
From page 30... ...
For example, training awards are used to train the next generation of cancer investigators, while IDEA Awards, first instituted by BCRP in FY 1996, fund high-risk research projects that have the potential for large breakthroughs. Although IDEA Awards, which have now been adopted by other CDMRP programs, do not generally require the preliminary data that are typically required through other funding mechanisms, but proposals are still expected to be based on sound scientific principles.
|
From page 31... ...
CDMRP has discussed the use of the SBIR model in some of its programs, particularly in looking at clinical and translation research in clinical trials, with the goal of providing more support in the drug development process, perhaps through Phase I or Phase II. Examples of Partnerships A central theme of almost all of the CDMRP award mechanisms is finding and funding the best and most innovative research aimed at eradicating disease.
|
From page 32... ...
In addition, CDMRP recently increased its effort to increase public awareness of its programs through advertising specific award mechanisms in national newspapers, distributing award information to consumer advocacy groups, and sponsoring funded investigators to attend scientific meetings. More than 4,500 publications have resulted from CDMRP awards through FY 2001 and CDMRP staff has published articles and presented information at national scientific meetings.
|
From page 33... ...
The committee views leveraging that is intended to increase research results as preferable to leveraging that is intended simply to extend program funding, because the latter tends to shift funding without increasing social benefit. This position is consistent with recent federal policy changes regarding cost sharing, which will be discussed in Chapter 4.
|
From page 34... ...
The committee considered whether federal rules and regulations would have to be revised to address bioethical concerns or peer review biases that might result from collaborative funding mechanisms or from the infusion of nonfederal funds into the DOD programs. Chapter 2 of this report focuses on sources of nonfederal funding, summarizing the statistics on funding of biomedical research by sector (industry, academia, other nonprofits, venture capital, and state government)
|
From page 35... ...
REFERENCES Andejeski Y, Breslau ES, Hart E, Lythcott N, Alexander L, Rich I, Bisceglio I, Smith HS, Visco FM, and the US Army Medical Research and Materiel Command Fiscal Year 1995 Breast Cancer Research Program Integration Panel.
|
From page 36... ...
Army's 1994 Breast Cancer Initiative." BioScience, 45(September)
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.