The ethics of placebo-controlled trials.

Abstract

Current Clinical Issues19 September 2000The Ethics of Placebo-Controlled TrialsTom ReynoldsTom ReynoldsSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-133-6-200009190-00103 SectionsAboutFull Text ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Placebo-controlled clinical trials are often considered the gold standard for evaluation of a new therapy because they are thought to provide the most definitive test of efficacy. The U.S. Food and Drug Administration (FDA), which is charged with ensuring both safety and efficacy, frequently requires pharmaceutical companies to perform placebo-controlled trials before a new drug is approved.Critics of such trials, however, believe that it is unethical to give patients a placebo when an approved therapy exists, even when the required informed consent has been provided. For support, they point to the Declaration of Helsinki, a document first ratified by ... Author, Article, and Disclosure InformationAffiliations: PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoCorrection: Ethics of Placebo-Controlled Trials Metrics Cited byReferencesMagnesium and depression: a systematic reviewChallenges and opportunities: what we are learning from the clinical natalizumab experienceEthical dilemmas encountered during clinical drug trialsEthical Aspects of Placebo in Migraine ResearchThe ABC of pharmaceutical trial design: some basic principlesDeconstructing the Placebo Effect and Finding the Meaning ResponseDaniel E. Moerman, PhD and Wayne B. Jonas, MDPlacebos, Placebo Effect, and the Response to the Healing Situation: The Evolution of a ConceptCorrection: Ethics of Placebo-Controlled Trials 19 September 2000Volume 133, Issue 6Page: 491-492KeywordsBiologicsClinical trialsConflicts of interestDrug therapyDrugsEpidemiologyFood and Drug AdministrationResearch ethicsSafetyScientists ePublished: 19 September 2000 Issue Published: 19 September 2000 Copyright & PermissionsCopyright © 2000 by American College of Physicians. All Rights Reserved.Loading ...