From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies

J Med Ethics. 2017 Jun;43(6):391-400. doi: 10.1136/medethics-2016-103868. Epub 2017 Apr 13.

Abstract

Our goals are to (1) set forth and defend a multiprinciple system for selecting individuals who meet trial eligibility criteria to participate in early phase clinical trials testing chimeric antigen receptor (CAR T-cell) for acute lymphoblastic leukaemia when demand for participation exceeds spaces available in a trial; (2) show the relevance of these selection criteria to other breakthrough experimental therapies; (3) argue that distinct distributive justice criteria apply to breakthrough experimental therapies, standard research and healthcare and (4) argue that as evidence of benefit increases, the emphasis of justice in research shifts from protecting subjects from harm to ensuring fair access to benefits.

Keywords: Allocation of Health Care Resources; Clinical trials; Distributive Justice; Drugs and Drug Industry; Research Ethics.

MeSH terms

  • Adolescent
  • Biomedical Research / ethics
  • Child
  • Child, Preschool
  • Clinical Trials as Topic / ethics*
  • Ethics, Research
  • Evidence-Based Medicine / ethics
  • Female
  • Human Experimentation / ethics*
  • Humans
  • Infant
  • Informed Consent / ethics
  • Male
  • Molecular Targeted Therapy* / methods
  • Moral Obligations
  • Patient Selection / ethics*
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / therapy*
  • Quality Assurance, Health Care / ethics
  • Receptors, Antigen, T-Cell* / therapeutic use
  • Research Subjects*
  • Risk Assessment
  • Young Adult

Substances

  • CTL019 chimeric antigen receptor
  • Receptors, Antigen, T-Cell