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

Ayodele A Odutayo, Susan Dutton, Bethan Copsey

• Missteps in the design and conduct of phase 1 trials have resulted in morbidity and mortality.1,2 Empirical evidence to improve regulatory review of phase 1 trials is lacking. We studied the characteristics of phase 1 trials, frequency of harms, and dissemination of results.