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Title Ethics and Statistics in Randomized Clinical Trials
Author Royall RM
Year 1991
Journal Stat Sci
Volume 6
Issue 1
Pages 52-62
Link for Open Access
Link for DOI
Contributed_by Ronald Thisted, University of Chicago
Commentary This article is a thoughtful review of the ethical issues surrounding RCTs and their alternatives, written by and for statisticians. Royall argues that it is essential for statisticians to understand the ethical demands that the physician-patient relationship places on physicians, and how those demands can lead to the conclusion that a physician's participation in an RCT would not be ethically permitted. Royall draws the useful distinction between experimental trials, in which investigators "are quite unsure which treatment is better," and demonstration trials, in which the purpose is to demonstrate convincingly that a new treatment is better than an alternative. The latter, of course, presents more ethical difficulty. Royall argues that only experimental RCTs are ethical. [The situation of an RCT for a not-yet-approved drug, where the only possible things to offer the patient are a 50 percent shot at getting the new drug, vs. a 0 percent chance that comes with not enrolling in the trial, is not discussed.] Royall's analysis of the personal-care principle in the context of clinical trials is particularly valuable. The essay touches on ethical aspects of key features of many clinical trials, including blinding, informed consent, and adaptive assignment. It argues for more rigorous use of nonrandomized controls as a potential alternative to the RCT. Royall argues that the view that the RCT is the only scientifically sound method for determining treatment effectiveness is incorrect, based on a misunderstanding of Fisher's suggestion that only randomization provides a basis for statistical inference.
Reference_Subject Biostat_Ethics
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