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Community Equipoise and the Architecture of Clinical Research

Published online by Cambridge University Press:  29 July 2009

Jason H. T. Karlawish  and
John Lantos
Jason H. T. Karlawish
Affiliation:
is Fellow of Geriatric Medicine, Section of General Internal Medicine, The University of Chicago.
John Lantos
Affiliation:
is the associate director of the Center for Clinical Medical Ethics, the Pritzker School of Medicine, Department of Pediatrics, The University of Chicago.
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Extract

Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration (FDA) and Health and Human Services (HHS) regulations. When that equipoise ends, a drug is either not approved or becomes standard care.

Type
Special Section: Expanding the Boundaries of Bioethics
Information
Cambridge Quarterly of Healthcare Ethics , Volume 6 , Issue 4 , Fall 1997 , pp. 385 - 396
Copyright
Copyright © Cambridge University Press 1997

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51. These three points are, of course, only a limited treatment of these issues. In a subsequent paper, we plan to address them in greater detail.