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Báo cáo y học: "Equipoise, design bias and randomized controlled trials: the elusive ethics of new drugs – a comment"

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 drugs – a comment. | Available online http arthritis-research.eom content 7 1 E2 Letter Equipoise design bias and randomized controlled trials the elusive ethics of new drugs - a comment Wolfgang Schimetta1 Gabriele Poelz1 Werner Poelz1 Hans-Peter Haring2 and Franz Aichner2 Institute of Applied Systems Research and Statistics University of Linz Austria 2Department of Neurology Wagner-Jauregg State Hospital Linz Austria Corresponding author Wolfgang Schimetta schimett@ping.at Published 23 November 2004 Arthritis Res Ther 2005 7 E2 DOI 10.1186 ar1482 2004 BioMed Central Ltd We read with interest the article by Fries and Krishnan about equipoise design bias and randomized controlled trials 1 . It is important to stress that equipoise is not the principle underlying company-driven clinical trials which are doubtlessly necessary and useful for medical progress. As a rule companies clinical research departments cannot afford the risk that their hypotheses are invalid and thus that their trials will fail. Furthermore equipoise in non-commercial trials is a very complex issue which we do not intend to discuss here. So positive expected outcomes seems to be an interesting and realistic alternative to equipoise. We cannot however agree with the authors control group considerations. From our point of view it is not acceptable for subjects assigned to a control group to be denied standard treatment even if the mean expected outcome expected outcome in the verum group plus expected outcome in the control group divided by two is positive. One of the authors arguments for the admissibility of control group treatments below clinical standard is that patients are autonomous and can make decisions on their own. In the case of most health problems patients are under enormous mental pressure and are not necessarily able to weigh-up the pros and cons in an objective way. Furthermore the feasibility of a placebo-controlled trial should not depend on a company s estimation of by how far the new treatment .