Extending clinical equipoise to phase 1 trials involving patients: unresolved problems

Kennedy Inst Ethics J. 2010 Mar;20(1):75-98. doi: 10.1353/ken.0.0307.


Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines whether the principle of clinical equipoise can be used as a standard for assessing the ratio of risk to direct-benefit presented by drugs administered in one category of Phase 1 study--first-in-human trials involving patients. On the basis of the supporting evidence for, and architecture of, Phase 1 studies, the articles offers two provisional conclusions: (1) the risks of drug administration in such trials cannot generally be justified on therapeutic grounds but by appeal to the social value of the research; and (2) a framework for adjudicating the ratio of risk/social-value must be developed.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials, Phase I as Topic* / methods
  • Clinical Trials, Phase I as Topic* / standards
  • Ethics, Research
  • Humans
  • Research Subjects
  • Risk
  • Social Values
  • Therapeutic Equipoise*