Clinical Trials -- Are They Ethical?
New England Journal of Medicine. 1991 May 30; 324(22): 1589-1592.
Clinical trials, randomized, efficient, and credible, eliminate the variability and complexity of outcomes associated with complicated physiologic features in observational trials, and thus since the 1950s have become the preferred method of biomedical research. Passamani argues for the scientific soundness and ethical correctness of randomized trials, with attention to the conflict between the roles of physician and physician-scientist. Suggesting several requisites for properly designed trials, including informed consent, clinical equipose (protecting participants against toxicity), and the trial design as a critical test of therapeutic alternatives, he attacks the notion that randomized trials unethically disallow physicians from "playing hunches" by applying promising but unproven therapy. His conclusion is that treatment proven effective according to scientific randomized trials, and endorsed by a panel of physicians, is more ethical and certain, and is a preferred treatment to hunches. (KIE abstract)
Alternatives; Biomedical Research; Clinical Trials; Consent; Drugs; Heart Diseases; Human Experimentation; Informed Consent; Investigator Subject Relationship; Medicine; Patients; Physicians; Placebos; Random Selection; Research; Research Design; Risks and Benefits; Standards; Technology; Technology Assessment; Toxicity;
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National Depressive and Manic-Depressive Association Consensus Statement on the Use of Placebo in Clinical Trials of Mood Disorders Charney, Dennis S.; Nemeroff, Charles B; Lewis, Lydia; Laden, Sally K.; Gorman, Jack M.; Laska, Eugene M.; Borenstein, Michael; Bowden, Charles L.; Caplan, Arthur; Emslie, Graham J.; Evans, Dwight L.; Geller, Barbara; Grabowski, Lenore E.; Herson, Jay; Kalin, Ned H.; Keck, Paul E., Jr.; Kirsch, Irving; Krishnan, Ranga R.; Kupfer, David J.; Makuch, Robert W.; Miller, Franklin G.; Pardes, Herbert; Post, Robert; Reynolds, Mildred M.; Roberts, Laura; Rosenbaum, Jerrold F.; Rosenstein, Donald L.; Rubinow, David R.; Rush, A. John; Ryan, Neal D.; Sachs, Gary S.; Schatzberg, Alan F.; Solomon, Susan (National Depressive and Manic-Depressive Association. Consensus Development Panel, 2002-03)