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November 24, 1999

The Crisis in Clinical Research—Reply

Author Affiliations

Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999

JAMA. 1999;282(20):1913-1916. doi:10-1001/pubs.JAMA-ISSN-0098-7484-282-20-jbk1124

In Reply: The conflicts of interest to which Dr Lee refers are best left to the individual analyses of institutional review boards. Participants in clinical trials are not "subjects." They are our patients. Dr Genel and associates have put a great deal of effort into solutions to these serious problems, and all of us are very grateful for their productive, hard work.

Dr Rockey focuses entirely on 1 subset of MD investigators, those who do translational research from bench to bedside. Since we did not examine the loss of MD applications during the past 3 years by subset of clinical research, we cannot confirm or deny Rockey's belief that the loss of applications is preferential in that group. The 16% decline in MD-PhD applications suggests that laboratory-based MD investigators share the discomfort of MDs engaged in clinical trials, outcome analysts, and epidemiologists. To argue, however, that the new K23 and K24 grant programs will continue to reduce the opportunities for any particular subset of clinical researchers makes little sense. The review committees are using the definition of clinical research that our panel adopted. The new grants should help all clinical investigators to achieve funding. We hope that the potential beneficiaries of the grants will apply for them in substantial numbers.

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