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Critical Strain on a Fundamental Linchpin

Gordon H. Williams, MD; Diane W. Wara, MD; Paul Carbone, MD

JAMA. 1997;278(3):227-231.

Abstract
Context.
—Interest in clinical investigative careers has declined over the past 2 decades. While several factors are likely involved in this decline, one is the perceived difficulty in obtaining support for investigator-initiated clinical research projects.

Objective.
—To analyze the priority scores and funding rates of patient-oriented research (POR) compared with laboratory-oriented research (LOR) when grant applications to the National Institutes of Health (NIH) are reviewed by study sections of the NIH Division of Research Grants.

Design.
—Research grant applications submitted to NIH were classified by the applicant as involving human subjects or not (LOR). Those classified as involving human subjects were divided into clinical (POR) and nonclinical research. The association of priority score and POR or LOR status was evaluated using ² statistical techniques.

Setting and Participants.
—Twelve thousand investigator-initiated grant applications (RO1s) in 2 of the 1994 NIH review cycles.

Main Outcome measures.
—Grant application priority scores and funding rates.

Results.
—On the basis of the following 3 criteria, POR applications fare less well than LOR applications: (1) POR status and ranking in the total application pool; (2) percentage of POR vs LOR applications in the top 20th percentile; and (3) funding rates of POR applications. Furthermore, the fate of a POR application depended on which study section reviewed the application. Those applications that were reviewed in study sections that primarily reviewed POR applications fared equivalently to LOR applications; in contrast, POR applications reviewed in study sections that primarily reviewed LOR applications encountered a less favorable fate.

Conclusions.
—These objective data provide strong support to the clinical research community's concern that investigator-initiated POR applications are not reviewed equitably at the NIH. By restructuring the review process, fairness is likely to be restored. Without restructuring, the POR component of the medical research community may be critically damaged.

Author Affiliations
From the Harvard Medical School and Brigham and Women's Hospital, Boston, Mass (Dr Williams); the University of California, San Francisco, School of Medicine (Dr Wara); and the University of Wisconsin Medical School, Madison (Dr Carbone).

Footnotes
Reprints: Gordon H. Williams, MD, Endocrine-Hypertension Division, Brigham and Women's Hospital, 221 Longwood Ave, Boston, MA 02115

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