Equipoise in clinical trials

Miller and Brody argue that the notion of clinical equipoise is fundamentally misguided. The ethics of therapy and the ethics of research are two distinct enterprises that are governed by different norms. They state, “The doctrine of clinical equipoise is intended to act as a bridge between therapy and research, allegedly making it possible to conduct RCTs without sacrificing the therapeutic obligation of physicians to provide treatment according to a scientifically validated standard of care. This constitutes therapeutic misconception concerning the ethics of clinical trials, analogous to the tendency of patient volunteers to confuse treatment in the context of RCTs with routine medical care.” [5] Equipoise, they argue, only makes sense as a normative assumption for clinical trials if one assumes that researchers have therapeutic obligations to their research participants. Further criticisms of clinical equipoise have been leveled by Robert Veatch [6] and by Peter Ubel and Robert Silbergleit. [7]

Let’s also assume that the standard treatment is known to have a mean response rate of 25 percent. Since there is typically much more evidence about the standard treatment, there will also be less uncertainty around this estimate (., 95 percent confidence interval ranges from 15 to 35 percent). We can thus establish that there ought to be a state of clinical equipoise: since the confidence intervals of our average effect estimates for these two treatments overlap, there is legitimate scientific uncertainty about which is better. Furthermore, since the interval for MX320 does not fall below the interval for standard treatment, then both are consistent with competent medical care.

Equipoise in clinical trials

equipoise in clinical trials

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