A Closer Look at the Bad Deal Trial: Beyond Clinical Equipoise‪.‬

In an important recent article, Franklin Miller and Howard Brody argued that we should reject the concept of clinical equipoise as an ethical requirement for regulating clinical research. (1) The requirement of clinical equipoise holds that there must be genuine uncertainty in the medical community as to whether the different treatment options used in a research study are superior to one another. (2) This requirement is derived from the principles of therapeutic beneficence and nonmaleficence that apply in the traditional relationship between physician and patient. Miller and Brody contend that clinical equipoise should be rejected because the context of clinical research is fundamentally different from the context of medical therapy. Unlike medical therapy, the basic purpose of clinical research is to advance generalizable scientific knowledge, not to promote the best interests of research subjects. Moreover, as Miller and Brody point out, many placebo-controlled trials simply cannot be squared with the requirement of clinical equipoise. Yet such trials are routinely carried out. Thus there is a gap between the requirement of clinical equipoise and the practice of clinical research. (3)