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Báo cáo y học: "Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development"

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: Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development. | Arthritis Research Therapy Vol 6 No 3 Fries and Krishnan Research article Open Access Equipoise design bias and randomized controlled trials the elusive ethics of new drug development James F Fries and Eswar Krishnan Stanford University School of Medicine Palo Alto California USA Corresponding author James F Fries e-mail jff@stanford.edu Received 4 Feb 2004 Revisions requested 24 Feb 2004 Revisions received 24 Feb 2004 Accepted 3 Mar 2004 Published 1 8 Mar 2004 Arthritis Res Ther 2004 6 R250-R255 DOI 10.1186 ar1170 2004 Fries and Krishnan licensee BioMed Central Ltd. This is an Open Access article verbatim copying and redistribution of this article are permitted in all media for any purpose provided this notice is preserved along with the article s original URL. Abstract The concept of equipoise or the uncertainty principle has been represented as a central ethical principle and holds that a subject may be enrolled in a randomized controlled trial RCT only if there is true uncertainty about which of the trial arms is most likely to benefit the patient. We sought to estimate the frequency with which equipoise conditions were met in industry-sponsored RCTs in rheumatology to explore the reasons for any deviations from equipoise to examine the concept of design bias and to consider alternative ethical formulations that might improve subject safety and autonomy. We studied abstracts accepted for the 2001 American College of Rheumatology meetings that reported RCTs acknowledged industry sponsorship and had clinical end-points n 45 and examined the proportion of studies that favored the registration or marketing of the sponsor s drug. In every trial 45 45 results were favorable to the sponsor indicating that results could have been predicted in advance solely by knowledge of sponsorship P 0.0001 . Equipoise clearly was being systematically violated. Publication bias appeared to be an incomplete explanation for this dramatic result this bias occurs after a study is .