Bibliographical noteFunding Information:
Traditionally, the NHLBI has sought to initiate and support trails via a variety of mechanisms. Among the extramural lipid/atherosclerosis trials funded by the NHLBI, the Minnesota Coronary Survey \[5\]t, he Coronary Drug Project (CDP) \[6\]t, he Cholesterol Lowering Atherosclerosis Study (CLAS) \[7\]a, nd the Program on Surgical Control of the Hyperlipidemias (POSCH) \[8\]a, re all examples of investigator-initiated, grant-funded trials. Examples of institute-initiated, contract-funded trials include the Multiple R~sk Factor Intervention TRIAL (MRFIT) \[9\]t,h e Lipid Research Clinics-Coronary Primary Prevention Trial (LRC-CPPT) \[10\]a, nd the Post-Coronary Artery Bypass Graft (Post-CABG) Trial \[11\]T. he recent request for application (RFA) from the NHLBI for a multicenter study of postprandial lipoproteins and atherosclerosis would modify grant funding via a cooperative agreement.
Even before the creation of this "Brave New World" atmosphere, the administration of clinical trials has not been performed in an even-handed fashion. The perception of conflict of interest is certainly present when the same Institute staff and Director administer both contracts and grants in the clinical trials arena. Promotion and career advancement within an Institute, as well as enhanced attractiveness for a high position m academia, industry, or government, are more likely to be related to successful performance for Institute-initiated programs rather than supporting the work of others. W~II not Institute staff favor programs initiated by them, controlled by them, advocated by them before the world media, and featuring them as pnnc~pal authors in the scientific literature? Is it realistic to ask Institute staff and their Director to give equal attention and sustenance to trials funded under the grant mechanism, as opposed to those funded by contracts, if they perceive that such support runs contrary to their own interest? The potential for success, publicity, and peer recognition associated with government-imt~ated, contract-supported, trials places NIH staff in a position of conflict of ~nterest with respect to the administration of investigator-initiated, grant-supported trials.
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