title: Extending clinical equipoise to phase 1 trials involving patients: unresolved problems.
abstract: 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.
authors.affiliation: Biomedical Ethics Unit, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.
authors.forename: James A
authors.initials: JA
authors.lastname: Anderson
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kimmelman
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000379:methods / Q000592:standards; D032984:Ethics, Research; D006801:Humans; D035842:Research Subjects; D012306:Risk; D012945:Social Values; D057212:Therapeutic Equipoise