title: Dispensing with equipoise.
abstract: Equipoise is widely endorsed as a necessary requirement for ethical design and conduct of randomized controlled trials. Nevertheless, I argue in this article that the equipoise principle suffers from fundamental defects. In particular, equipoise provides flawed ethical guidance for placebo-controlled trials and for decisions to terminate trials early based on interim data relating to benefit. The problems with equipoise are traced to a "therapeutic orientation to clinical trials," which conflates the ethics of clinical research with the ethics of medical care. Because of this mistaken therapeutic orientation, equipoise fails to adequately account for the central purpose of randomized trials in providing evidence sufficient to guide health policy decisions relating to licensing new treatments and insurance coverage. I conclude that it is time to dispense with equipoise. The principles of research ethics are sufficient to provide adequate guidance to protect subjects and to promote socially valuable research without any appeal to equipoise.
authors.affiliation: Department of Bioethics, Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892-1156, USA. fmiller@nih.gov
authors.forename: Franklin G
authors.initials: FG
authors.lastname: Miller
mesh_terms: D026688:Bioethical Issues; D018849:Controlled Clinical Trials as Topic / Q000941:ethics; D006291:Health Policy; D006801:Humans; D015990:Placebo Effect; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D057212:Therapeutic Equipoise