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Ethical Implications of Rejecting Patients for Clinical Trials

Thomas C. Chalmers, MD
JAMA. 1990;263(6):865. doi:10.1001/jama.1990.03440060111043.
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Once in a blue moon, the request for an editorial to accompany a scientific article creates an opportunity to make an ethical point that is both new and important. Such an opportunity is presented by the article in this issue of JAMA entitled "The Quality of Life of Hemodialysis Recipients Treated With Recombinant Human Erythropoietin."1 To quote from the "Patients and Methods" section, "The investigators, in consultation with representatives of the Food and Drug Administration, concluded that a randomized study involving the administration of a placebo was ethically indefensible." Presumably the ethical reasoning was that anyone asked to volunteer for randomization would be sacrificing his or her own health for the good of the study and future patients. That is the standard argument against randomization when there is a reasonable likelihood that the new therapy will be better than the old. It falls down when the expected improvement is entirely


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