title: Initiating large-scale clinical trials.
abstract: Large-scale clinical trials and their great potential impact on medical practice and on future research require extensive resources. Therefore, decisions to undertake such clinical trials must be made analytically and deliberately. This paper focuses on the decision and management processes used to initiate clinical trials in the National Heart, Lung, and Blood Institute, emphasizing the basis or rationale for the Institute to undertake a trial. The paper discusses two recent examples of the application of the process--a trial on drug treatment for mild hypertension that was considered and rejected by the Institute, and a trial on the effect of beta-blocker drugs to reduce post-myocardial infarction mortality, a trial that is now underway.
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D006331:Heart Diseases / Q000517:prevention & control; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D009316:National Institutes of Health (U.S.); D012008:Recurrence; D012107:Research Design; D012306:Risk; D014481:United States
chemical_list: D000319:Adrenergic beta-Antagonists