Characteristics and Dissemination of Phase 1 Trials Approved by a UK Regional Office in 2012.

Odutayo, Ayodele; Copsey, Bethan; Dutton, Susan; Cook, Jonathan; Hopewell, Sally; Altman, Douglas G · JAMA · 2017

retrospective_cohort · Level III

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Abstract

This study describes characteristics of phase 1 trials, frequency of harms, and communication between investigators and research ethics committees about adverse events to characterize the safety and improve the regulatory review of UK phase 1 trials.

Medical subject headings