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From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies
  1. Nancy S Jecker1,
  2. Aaron G Wightman2,
  3. Abby R Rosenberg3,
  4. Douglas S Diekema4
  1. 1University of Washington School of Medicine, Department of Bioethics & Humanities, Seattle, Washington, USA
  2. 2University of Washington School of Medicine, Department of Pediatrics and Seattle Children's Hospital, Division of Nephrology, Seattle, Washington, USA
  3. 3University of Washington School of Medicine, Department of Pediatrics and Seattle Children's Hospital, Division of Hematology-Oncology, Seattle, Washington, USA
  4. 4University of Washington Department of Pediatrics and Seattle Children’s Hospital, Division of Emergency Medicine, Seattle, Washington, USA
  1. Correspondence to Dr Nancy S Jecker, Department of Bioethics & Humanities, University of Washington School of Medicine, 1959 Pacific Street, Box 357120, Seattle, WA 98195-7120, USA; nsjecker{at}uw.edu

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.

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Footnotes

  • Competing interests None declared.

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

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