There is much to be gained from large-scale biomedical research projects, so think big and set up a system for assessing, staffing, conducting, and monitoring big projects, advised the Institute of Medicine (IOM) in a new report, "Large-Scale Biomedical Science: Exploring Strategies for Future Research."
In seven recommendations, the report lays out steps that federal agencies should consider when planning large-scale projects. The first three address ways these projects could be evaluated, funded, conducted, and monitored. The remaining four are aimed at outlining issues that future large-scale projects might face: the need to recruit high-caliber personnel, licensing of intellectual property, and developing cooperative arrangements with industry.
None of the large projects initiated by the National Cancer Institute to date have been systematically evaluated, the report points out. "There is a need to get a grip on this," commented Richard Rettig, Ph.D., a social science researcher with the RAND Corp., in Alexandria, Va., and author of a book, Cancer Crusade, on the development of the 1971 National Cancer Act.
As a step in this direction, the report calls on government agencies, such as the National Institutes of Health, to develop ways for assessing important new research opportunities in which a large-scale approach is likely to achieve results more effectively or efficiently than small groups of investigator initiated researchthe type traditionally funded by NIH.
The report was written by an IOM committee specifically created to deal with and make recommendations regarding the conduct of large-scale biomedical research, but it has its origins in the application of such projects to cancer. Of the 24 members of the committee, 19 are members of the IOMs National Cancer Policy Board and the chair is Joseph V. Simone, M.D., a well-known cancer researcher, who now runs a consulting concern in Dunwoody, Ga. However, as their work went forward, committee members noted: "It quickly became clear that all fields of biomedical research could benefit from the committees recommendations."
"The recent interest in adopting large-scale research methods has generated questions as to how such studies should be financed and conducted," the report stated. It cites the Human Genome Project, which started as a formal federal program in 1991, as the trigger of this interest. But large-scale projects are hardly new. In 1955, the NCI developed the Cancer Chemotherapy Program and in 1964 the Cancer Virus Program. More recently, in 2000, the Protein Structure Initiative was mounted by the National Institute of General Medical Sciences, and in 1998 the NCI started the Single Nucleotide Polymorphism consortium. The committee briefly reviewed many of these to see what lessons they might provide. Although the efforts vary widely, there are many common themes. They require expensive and often novel technologies and they need careful planning, organization, and oversight.
The committee warned against using such projects as a way of establishing permanent infrastructures such as centers or institutes. "Historically, NIH has not had a good mechanism for phasing out established research programs, but large-scale projects should not become institutionalized by default simply because of their size." As committee member Ellen Stovall, executive director of the National Coalition for Cancer Survivorship commented, "This report says you should evaluate these projects, plan them, supervise them, and at the end phase them out."
In an interview, Stovall raised the concern of the scientist who sees expensive large-scale projects taking funds from the pool of funds available for individual, investigator-oriented research. "Every time you put another fish in that pond, it leaves a little less food for the others. And these large-scale science projects take up a lot of food," she noted.
Nevertheless, NIH seems committed to conducting large-scale projects when they are appropriate. NIH director Elias A. Zerhouni, M.D., recently told his advisory council that the agencys future includes a greater emphasis on what he termed "revolutionary methods of research" that focus on scientific questions too complex to be addressed by the single-investigator approach and indicated that the NIH grant process will need to be adapted to accommodate this approach to scientific investigation.
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