The Importance of the 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 the authors the problem of 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. The authors 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."