Clinical Trials

Biography

Biography: Scott Gelfand

Abstract

In 1972, Charles Fried, in Medical Experimentation: Personal Integrity and Social Policy asserted that physician-researchers have an ethical obligation to be in a state of equipoise during all stages of randomized clinical trials. Fried’s equipoise requirement dictates that a physician engaged in research must not believe that one experimental arm of a randomized clinical trial is better or more efficacious than the other arms (must be in a state of equipoise). Although the equipoise requirement has been modified over the course of the last 45 years, the equipoise requirement is currently the fundamental or guiding principle concerning the ethics of enrolling patients in randomized clinical trials. In this talk I will discuss the ethical foundation for the equipoise requirement, what is the current equipoise requirement and ethical/practical problems associated with the equipoise requirement.