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Equipoise and the Dilemma of Randomized Clinical Trials

List of authors.
  • Franklin G. Miller, Ph.D.,
  • and Steven Joffe, M.D., M.P.H.

Clinical equipoise, or uncertainty about which treatment is best for a patient, is widely viewed as essential for an ethical RCT. The authors argue that clinical trials that violate equipoise are ethical and necessary to inform societal decisions about drug approval and coverage.

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Funding and Disclosures

The opinions expressed are those of the authors and do not necessarily reflect the position or policy of the National Institutes of Health, the Public Health Service, or the Department of Health and Human Services.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Author Affiliations

From the Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD (F.G.M.); and the Department of Pediatric Oncology, Dana–Farber Cancer Institute, and the Department of Medicine, Children's Hospital Boston — both in Boston (S.J.).

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