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.
Kimmelman J, Waligora M, Lynch HF. Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials—Reply. JAMA Pediatr. Published online April 22, 2019173(6):609–610. doi:10.1001/jamapediatrics.2019.0797
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