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Title Clinical Trials--Are They Ethical?
Author Passamani E.
Year 1991
Journal N Engl J Med
Volume 324
Pages 1589-1592
Link for Open Access
Link for DOI
Contributed_by Ronald Thisted, University of Chicago
Commentary In this second of two Sounding Board essays on the ethics of randomized trials (see Hellman and Hellman, 1991), Passamani argues that randomized trials are "the most ethically correct means of evaluating new therapies." Passamani recognizes that clinical trials can impinge on the physician-patient relationship, but that ethical difficulties can successfully be addressed through elements of study design. For Passamani, the ethical cornerstones of the RCT are informed consent (which Hellman and Hellman reject), and clinical equipoise (a lack of which Passamani defines in terms of one treatment being clearly established as superior, while Hellman and Hellman define in terms of a preference or even a hunch that one treatment is better than the other). The data and safety monitoring board is an ethical surrogate for the physician and patient, to terminate a study when clinical equipoise no longer holds. A key distinction is between proven and unproven therapies; RCTs involving the former do compromise the physician-patient relationship, while those involving the latter need not.
Reference_Subject Biostat_Ethics
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