Equipoise, design bias and randomized controlled trials: the elusive ethics of new drugs – a comment

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.