David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
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American Journal of Bioethics 2 (2):3 – 9 (2002)
The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm.
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Citations of this work BETA
Adnan A. Hyder, Abbas Rattani, Carleigh Krubiner, Abdulgafoor M. Bachani & Nhan T. Tran (2014). Ethical Review of Health Systems Research in Low- and Middle-Income Countries: A Conceptual Exploration. American Journal of Bioethics 14 (2):28-37.
Rosamond Rhodes (2005). Rethinking Research Ethics. American Journal of Bioethics 5 (1):7 – 28.
Jeremy Howick (2009). Questioning the Methodologic Superiority of 'Placebo' Over 'Active' Controlled Trials. American Journal of Bioethics 9 (9):34-48.
Winston Chiong (2006). The Real Problem with Equipoise. American Journal of Bioethics 6 (4):37 – 47.
E. Haavi Morreim (2005). The Clinical Investigator as Fiduciary: Discarding a Misguided Idea. Journal of Law, Medicine & Ethics 33 (3):586-598.
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