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Comment & Response
April 22, 2019

Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials—Reply

Author Affiliations
  • 1Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada
  • 2Research Ethics in Medicine Study Group, Department of Philosophy and Bioethics, Jagiellonian University Medical College, Krakow, Poland
  • 3Department of Medical Ethics and Health Policy, Perelman School of Medicine, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia
JAMA Pediatr. 2019;173(6):609-610. doi:10.1001/jamapediatrics.2019.0797

In Reply Pediatric phase 1 cancer trials are widely viewed as offering a therapeutic opportunity for children who meet eligibility criteria, which typically include exhaustion of other treatment options.1,2 This perspective likely grounds the way such trials are reviewed by local ethics committees, as well as what children and their guardians are told during recruitment and informed consent. Our commentary,3 which was prompted by a 2018 systematic review,4 presses for a re-evaluation of the assumption of potential therapeutic benefit in this context.

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