To the Editor: The Viewpoint by Kimmelman et al1 frames the protection of pediatric phase 1 trial participants primarily as a question of what we may approve, rather than of what we can improve. It supposes that dangers to these participants arise chiefly from investigators’ and parents’ unreasonable optimism. Participant protection thus reduces to restraining these biased actors.
Norris DC. Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials. JAMA Pediatr. Published online April 22, 2019173(6):609. doi:10.1001/jamapediatrics.2019.0811
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