Equipoise and uncertainty, or the ethical dilema of randomized clinical trials

Abstract

Randomized controlled trials (RCT) are considered the best design for testing the efficacy of an intervention. Clinical research employing this design has been considered to pose an ethical dilemma. On one hand, each patient requires the treatment that best meets his or her needs, as judged by his or her doctor in agreement with the patient’s requirements. On the other hand, the randomized trial necessitates that each patient’s care is decided neither by the physician nor the patient but instead by random assignment. The tension may be described, in a generic sense, as a conflict between the therapeutic interests of individual patients and the interests of the whole population that would benefit from advances in medical understanding and research. This manuscript covers some of the history of research ethics since 1970, and how two apparently opposite ethical approaches have tried to solve these concerns about the distinction between research and therapy; which, at the end, is supposed to be the underlying question in therapeutic clinical research.