A Surplus of Positive Trials: Weighing Biases and Reconsidering Equipoise


Show simple item record Felson, David T en_US Glantz, Leonard en_US 2012-01-09T20:51:29Z 2012-01-09T20:51:29Z 2004-4-27 en_US
dc.identifier.citation Felson, David T, Leonard Glantz. "A surplus of positive trials: weighing biases and reconsidering equipoise" Arthritis Research & Therapy 6(3): 117-119. (2004) en_US
dc.identifier.issn 1478-6362 en_US
dc.description.abstract In 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.iso en en_US
dc.publisher BioMed Central en_US
dc.subject Clinical trials en_US
dc.subject Equipoise en_US
dc.subject Ethics en_US
dc.subject Publication bias en_US
dc.title A Surplus of Positive Trials: Weighing Biases and Reconsidering Equipoise en_US
dc.type article en_US
dc.identifier.doi 10.1186/ar1189 en_US
dc.identifier.pubmedid 15142261 en_US
dc.identifier.pmcid 416455 en_US

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