April 1998 Bulletin

Research/Laura Pelehach

Policymakers act to boost clinical research

Moving investigation from ‘endangered species’ list

Clinical researchers may someday find it easier to obtain federal funding for their research proposals, as the National Institutes of Health (NIH), the Clinton administration and legislators recommend measures to bolster the branch of research some have dubbed an "endangered species." The proposed measures seek to increase clinical research training and ensure that clinical researchers are fairly represented on NIH panels that review research proposals.

In recent years, training for potential clinical researchers has been hampered by mentor shortages, long training programs that place medical students further into debt, and cuts in funding for training programs and clinical research in institutions due to managed care and reduced reimbursement. Furthermore, recent years have shown a sharp decline in the number of first-time MD investigators applying for NIH grants, an increase in the ratio of PhDs-to-MDs applying for grants, and less of an inclination for MDs to reapply for grants after their initial proposals are rejected.

To address these issues, the NIH director’s Panel on Clinical Research recently provided recommendations to an advisory committee to the NIH director. The recommendations stem from a two-year study by the panel, which formed in response to a 1994 Institute of Medicine report that stated that clinical research proposals were far less successful than basic research proposals in winning NIH grants. Although the panel found that the current fraction of the extramural portion of the NIH budget devoted to clinical research was reasonable, it provided recommendations for ongoing review and analysis. Among other recommendations were to:

President Clinton’s proposed budget for fiscal year 1999 further seeks to strengthen clinical research through creation of a Research Fund for America that proposes to increase the NIH budget by more than half over the next five years to $20.2 billion. A $1.5 billion increase in 1999 for the NIH would result in $132 million to improve the "research infrastructure," which includes clinical research.

In another move to help bring basic research breakthroughs to the bedside, Sen. Edward M. Kennedy (D-Mass.) and Rep. Nita Lowey (D-N.Y.) introduced legislation - S. 1421 and HR 3001, the Clinical Research Enhancement Act of 1997 - that would, among other provisions, create a new award for clinical investigators who pursue initial research projects with a mentor prior to independent pursuit of research, create medical science awards for researchers in order to improve funding for projects involving potential clinical applications of basic discoveries, provide support for scientists seeking advanced degrees in clinical investigation and expand the loan repayment program for clinical researchers. S. 1421 has been referred to the Senate Labor and Human Resources Committee and H.R. 3001 has been referred to the House Subcommittee on Health and the Environment. There has been no further action on the bills.

Michael G. Ehrlich, M.D., chairman of the Academy’s committee on research, says that the degree by which orthopaedists benefit from these measures will depend, in large part on the orthopaedists themselves. With the NIH’s assurance that clinical researchers will serve on NIH panels, Dr. Erhlich says that orthopaedists should seek representation on the panels. "The orthopaedic community must volunteer its people to serve on the NIH study sections," he says. Although he observes that orthopaedists have always performed clinical research, much of it is not funded and the new measures may open the door for funding.

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