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Title Hellman S, Hellman DS.Problems of the Randomized Clinical Trial
Author Hellman S, Hellman DS
Year 1991
Journal N Engl J Med
Volume 324
Pages 1585-1589
Link for Open Access
Link for DOI
Contributed_by Ronald Thisted, University of Chicago
Commentary Hellman and Hellman argue that physician participation in randomized clinical trials almost always violates the physician's duty to individual patients. In many respects, this essay echoes that of Royall (1991). The heart of the argument is that physicians are rarely in equipoise, and that in such circumstances it is unethical for them to ask their patients to enroll in a trial. Although some of the critiques of the RCT are based on misunderstandings (randomization does not entail blinding, for instance), Hellman and Hellman identify potential effects that a clinical trial can place on the physician-patient relationship. The potential effects are critical to understand and, where possible, to ameliorate through appropriate study design. Some of the alternative designs the authors suggest present difficult statistical challenges. The essay's discussion of AIDS activism is particularly interesting from a historical standpoint; Hellman and Hellman point to the arguments then being put forth by AIDS activists against random assignment as supportive of their thesis. Well after this paper's publication, the community of AIDS activists moved largely into the camp that RCTs were not only necessary and ethical, they were the only ethical way to move forward. This paper is one of two Sounding Board essays published together on this topic. (See also Passamani, 1991).
Reference_Subject Biostat_Ethics
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