Equipoise clinical research

Equipoise, or the criterion of honest professional uncertainty in the clinical community, is currently the most widely accepted standard for adjudicating the ethical dilemmas of medical research involving human patients. Nonetheless, equipoise has recently become a subject of considerable criticism. Among the objections to equipoise, an important one is based on the observation of an objective difficulty for equipoise in providing sound ethical guidance in practical circumstances that arise in clinical research. A chief example of such problem is represented by the case of monitoring accumulating data from a trial. In this article we argue that the perceived inadequacy of equipoise in this context is caused by a widespread misconception of the relation between equipoise and more fundamental ethical principles. We argue that, when interpreted as a mid-level principle (Rachels, 2009), the value of equipoise as the appropriate ethical guidance for clinical research becomes more firmly established.

The responsibilities delegated to steering committees or contract research organizations (CROs) by a manufacturer and/or funding agency can vary considerably. It is important that the responsibilities and authorities of the product manufacturer, the funding organization (if different) and any other entity be clearly defined and understood by all parties at the start of the endeavor. Potential conflicts of interest of each party, especially sponsors and clinical investigators (see 21 CFR Part 54) should be carefully considered when determining roles and responsibilities.

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]

Equipoise clinical research

equipoise clinical research


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