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Learning health systems, clinical equipoise and the ethics of response adaptive randomisation
  1. Alex John London
  1. Correspondence to Dr Alex John London, Center for Ethics and Policy, Carnegie Mellon University, Pittsburgh, PA 15213-3890, USA; ajlondon{at}andrew.cmu.edu

Abstract

To give substance to the rhetoric of ‘learning health systems’, a variety of novel trial designs are being explored to more seamlessly integrate research with medical practice, reduce study duration and reduce the number of participants allocated to ineffective interventions. Many of these designs rely on response adaptive randomisation (RAR). However, critics charge that RAR is unethical on the grounds that it violates the principle of equipoise. In this paper, I reconstruct critiques of RAR as holding that it is inconsistent with five important ethical principles. I then argue that these criticisms rest on a faulty view of equipoise encouraged by the idea that a RAR study models the beliefs of a single rational agent about the relative merits of the interventions being studied. I outline a view in which RAR models an idealised health system in which diverse communities of fully informed experts shrink or grow as their constituent members update their expert opinions in light of reliable medical evidence. I show how a proper understanding of clinical equipoise can reconcile this conception of RAR with these five ethical principles. This analysis removes an in-principle objection to RAR and sheds important light on the relationship between clinical equipoise and transient diversity in the scientific community.

  • research ethics
  • clinical trials
  • biostatistics
  • ethics
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Footnotes

  • Contributors AJL conceived and wrote this paper.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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