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Executive Summary

CONFLICT-OF-INTEREST GUIDELINES ESTABLISHED IN NHLBI TRIAL: Investigators conducting a National Heart, Lung and Blood Institute-sponsored clinical trial using cholesterol-lowering agents have established their own conflict-of-interest guidelines that prohibit them from buying, selling, or holding stock or stock options in companies providing drugs for their study during the investigators' active involvement in the trial. The trial involves use of Merck's Mevacor (lovastatin), Dupont's Warfarin (coumadin) and Bristol-Myer's Questran (cholestyramine). The investigators, Bernadine Healy, Cleveland Clinic Foundation, et al, are conducting the Post Coronary Artery Bypass Graft Surgery (Post-CABG) trial. Their conflict-of-interest guidelines are published in the April 6 issue of the New England Journal of Medicine. The Post-CABG study is a multicenter, randomized, double-blind study that is to "determine whether stringent reduction of cholesterol levels and antithrombotic treatment can limit the development of atherosclerosis in the implanted saphenous-vein grafts," the investigators note. The researchers explain that such guidelines are necessary for their study because: "We believe that a defined conflict-of-interest policy will protect the integrity of the study and the credibility of the investigators as the trial is scrutinized by the scientific community and the public." Because the trial "will test the usefulness of specific pharmacologic agents with respect to the major endpoints of the study, beneficial or negative results could affect the use, sale and profitability of the drugs under study," Healy, et al, note. The investigators say they developed the guidelines to "eliminate any suggestion that the conduct of the research is influenced by personal financial interests." The guidelines also prohibit the investigators and their dependents from serving as paid consultants to the drug companies during the study period. Annual conflict-of-interest statements will be submitted by each investigator and activities such as an investigator's involvement in unpaid consulting, educational activities, or other research projects with the companies must be reported. Healy, et al, assert that the guidelines should not only apply to the principal investigator of the study, but to all key investigators. They also suggest that "consideration be given to developing similar conflict-of-interest guidelines for members of data and safety monitoring boards," who also have access to confidential data. The guidelines were "agreed to by all participating centers before the enrollment of patients in the trial," Healy, et al, state. In an editorial in the same issue of the Journal, NEJM editor Arnold Relman praises the Post-CABG rules as "laudable voluntary guidelines, which for the time being other clinical investigators would do well to adopt." He adds that "a broader and more institutionalized approach is needed, however."

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