tailieunhanh - Báo cáo y học: "A surplus of positive trials: weighing biases and reconsidering equipoise"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học General Psychiatry cung cấp cho các bạn kiến thức về ngành y đề tài: A surplus of positive trials: weighing biases and reconsidering equipoise. | Available online http content 6 3 117 Commentary A surplus of positive trials weighing biases and reconsidering equipoise David T Felson1 and Leonard Glantz2 Boston University School of Medicine Boston Massachusetts USA 2Boston University School of Public Health Boston Massachusetts USA Corresponding author David Felson e-mail dfelson@ Received 5 Apr 2004 Accepted 15 Apr 2004 Published 27 Apr 2004 Arthritis Res Ther 2004 6 117-119 DOI ar1189 2004 BioMed Central Ltd 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. Keywords clinical trials equipoise ethics publication bias In this issue Fries and Krishnan 1 raise provocative new ideas that account for the surfeit of positive industry controlled trials evaluating new drugs. .