The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.
Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."
Djulbegovic
Benjamin
B
Department of Interdisciplinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, University of South Florida, 12902 Magnolia Dr., Tampa, FL 33612, USA. djulbebm@moffitt.usf.edu
Cantor
Alan
A
Clarke
Mike
M
D015982:Bias; D035061:Control Groups; D003627:Data Interpretation, Statistical; D004345:Drug Industry; D005069:Evaluation Studies as Topic; D017408:Guidelines as Topic; D006801:Humans; D010919:Placebos; D011786:Quality Control; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000379:methods* / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012109:Research Support as Topic; D035703:Therapies, Investigational / Q000145:classification; D035501:Uncertainty
D010919:Placebos