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dc.contributor.authorFelson, David T.en_US
dc.contributor.authorGlantz, Leonarden_US
dc.date.accessioned2012-01-09T20:51:29Z
dc.date.available2012-01-09T20:51:29Z
dc.date.issued2004-4-27
dc.identifier.citationFelson, David T, Leonard Glantz. "A surplus of positive trials: weighing biases and reconsidering equipoise" Arthritis Research & Therapy 6(3): 117-119. (2004)
dc.identifier.issn1478-6362
dc.identifier.urihttp://hdl.handle.net/2144/2873
dc.description.abstractIn this issue, Fries and Krishnan raise provocative new ideas to explain the surfeit of positive industry sponsored trials evaluating new drugs. They suggest that these trials were designed after so much preliminary work that they were bound to be positive (design bias) and that this violates clinical equipoise, which they characterize as an antiquated concept that should be replaced by a focus on subject autonomy in decision making and expected value for all treatments in a trial. We contend that publication bias, more than design bias, could account for the remarkably high prevalence of positive presented trials. Furthermore, even if all new drugs were efficacious, given the likelihood of type 2 errors, not all trials would be positive. We also suggest that clinical equipoise is a nuanced concept dependent on the existence of controversy about the relative value of two treatments being compared. If there were no controversy, then trials would be both unnecessary and unethical. The proposed idea of positive expected value is intriguing, but in the real world such clearly determinable values do not exist. Neither is it clear how investigators and sponsors, who are invested in the success of a proposed therapy, would (or whether they should) develop such a formula.en_US
dc.language.isoenen_US
dc.publisherBioMed Centralen_US
dc.subjectClinical trialsen_US
dc.subjectEquipoiseen_US
dc.subjectEthicsen_US
dc.subjectPublication biasen_US
dc.titleA Surplus of Positive Trials: Weighing Biases and Reconsidering Equipoiseen_US
dc.typearticleen_US
dc.identifier.doi10.1186/ar1189
dc.identifier.pubmedid15142261
dc.identifier.pmcid416455


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