Characteristics and Dissemination of Phase 1 Trials Approved by a UK Regional Office in 2012.
Odutayo A., Copsey B., Dutton S., Cook J., Hopewell S., Altman DG.
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.