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

• Autores: Ayodele A Odutayo, Susan Dutton, Bethan Copsey
• Localización: JAMA: the journal of the American Medical Association, ISSN 0098-7484, Vol. 317, Nº. 17, 2017, págs. 1799-1801
• Idioma: inglés
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• Resumen

  • 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.