Details

Autor(en) / Beteiligte

• Byar, David P
• Simon, Richard M
• Friedewald, William T
• Schlesselman, James J
• DeMets, David L
• Ellenberg, Jonas H
• Gail, Mitchell H
• Ware, James H

Titel

Randomized Clinical Trials: Perspectives on Some Recent Ideas

Ist Teil von

• The New England journal of medicine, 1976-07, Vol.295 (2), p.74-80

Ort / Verlag

United States: Massachusetts Medical Society

Erscheinungsjahr

1976

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• In spite of the controversy over the role of randomized clinical trials in medical research, the rationale underlying such trials remains persuasive as compared to recent suggestions for alternative nonrandomized studies such as those relying on the use of historical controls and adjustment technics. Others have suggested that recent statistical innovations for improving clinical trials, including adaptive allocation of treatment to patients and sequential stopping procedures, are underutilized. These innovations, though theoretically interesting, are not easily adapted to large-scale, complex medical trials in which there may be multiple end points and delayed response times. Ethical considerations suggest that randomized trials are more suitable than uncontrolled experimentation in protecting the interests of patients. Randomized clinical trials remain the most reliable method for evaluating the efficacy of therapies. (N Engl J Med 295:74–80, 1976) Three articles 1 2 3 have recently appeared in the Journal on the subject of controlled clinical trials. Chalmers et al. 1 discuss the point of view espoused by A.B. Hill that randomized clinical trials are necessary for the valid assessment of therapeutic efficacy. 4 , 5 In contrast, the papers by Gehan and Freireich 2 and Weinstein 3 have emphasized alternatives to the randomized clinical trial. Gehan and Freireich stressed the use of adjustment technics and recent historical controls. Weinstein also mentioned adjustment technics along with other topics such as sequential stopping procedures, decision-theoretic ideas, and novel methods of allocation of treatments to patients, including allowing the patient . . .