What makes placebo-controlled trials unethical?

Franklin G. Miller, Howard Brody

Research output: Contribution to journalArticle

162 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)3-9
Number of pages7
JournalThe American journal of bioethics : AJOB
Volume2
Issue number2
StatePublished - Mar 2002
Externally publishedYes

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Placebos
Therapeutics
Clinical Medicine
Controlled Clinical Trials
medicine
trial
Clinical Trials
Physicians
Research
boldenone undecylenate

ASJC Scopus subject areas

  • Management, Monitoring, Policy and Law

Cite this

What makes placebo-controlled trials unethical? / Miller, Franklin G.; Brody, Howard.

In: The American journal of bioethics : AJOB, Vol. 2, No. 2, 03.2002, p. 3-9.

Research output: Contribution to journalArticle

Miller, Franklin G. ; Brody, Howard. / What makes placebo-controlled trials unethical?. In: The American journal of bioethics : AJOB. 2002 ; Vol. 2, No. 2. pp. 3-9.
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