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Previous Volume 350:515-516 January 29, 2004 Number 5 Next

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To the Editor: Nathan and Wilson (Nov. 6 issue)¹ discuss the position of the National Institutes of Health (NIH) with respect to clinical research. The NIH is biased toward basic science and is prejudiced by the idea that clinical research is best performed in a university setting by means of prospective trials. However, many clinical questions cannot be addressed in this way, especially when the goal is to determine which established techniques are most effective in an era of cost containment. Doctors with access to the numbers of patients needed for both retrospective and prospective studies of outcomes are frequently not based at a university. These doctors are alienated from the research infrastructure and are inexperienced with grants, institutional review boards, and research budgets. In the past, they self-funded the publication of their results, but funding for this effort is drying up. The NIH needs to establish a mechanism to fund studies that address many of the everyday questions we face for which the evidence is meager.

Jeffrey L. Kaufman, M.D.
Vascular Services of Western New England
Springfield, MA 01107

References

1. Nathan DG, Wilson JD. Clinical research and the NIH -- a report card. N Engl J Med 2003;349:1860-1865. [Free Full Text]

Although the authors make interpretation needlessly difficult by conflating "investigators" and "applicants" with "applications," it appears (from their discussion and Table 2) that nearly 233 (a few applied for more than one grant) of the 255 recipients of NIH clinical grants in 1996 reapplied for funding, 49 through a type 2 renewal mechanism and 184 through a new application. This reapplication rate of approximately 91 percent is gratifying. Also encouraging is the success rate: 112 of 233 applicants (48 percent) received an award. In the nonclinical comparison cohort of 884 applicants, there were 965 type 1 and type 2 reapplications, but because of multiple applications the number of individual investigators who reapplied cannot be determined. Nonetheless, in neither cohort was there a substantial decrease in the number of investigators who reapplied, nor was there an alarming (81 percent) loss to the system of first-time clinical investigators. Because the data do not indicate whether all the type 1 reapplications from the clinical-research cohort could be considered "clinical-research" applications, one cannot determine what fraction of this cohort may have been lost to clinical research at the time of a first reapplication.

Although the production and retention of clinical investigators, especially physician-scientists, must be a priority for academic medical centers and the NIH, this article offers no insight into the environmental factors that play a crucial role in determining the fate of freshly minted clinical investigators in academic medicine. An understanding of these factors is crucial to the formulation of sound educational and funding policy.

Bruce Schneider, M.D.
David Korn, M.D.
Association of American Medical Colleges
Washington, DC 20037-1127
dkorn{at}aamc.org

As for their second point, our article was not intended to deal with the environment, about which much has been written. Instead, it describes the recent NIH response to the environment. But we are glad to see that the Association of American Medical Colleges agrees that academic health centers share responsibility for the unfavorable status of clinical research. That is a big step forward since 1995, when the NIH was often a singular depository of blame for the problem.

Dr. Kaufman is correct in pointing out that practicing physicians are in a perfect position to provide valuable data on outcomes. Indeed, very large group practices, such as Kaiser, are prominent recipients of NIH clinical-research grants. If sufficient numbers of practices could be brought together in a high-quality trials and outcomes system, we believe that the NIH would respond very favorably.

David G. Nathan, M.D.
Dana–Farber Cancer Institute
Boston, MA 02115

Jean D. Wilson, M.D.
University of Texas Southwestern Medical Center
Dallas, TX 75390

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