The regulation of COVID-19 clinical trials in Peru

Paula Cahuina Lope, Sarah Carracedo, Franco Romani

Producción científica: Contribución a una revistaArtículorevisión exhaustiva

5 Citas (Scopus)

Resumen

COVID-19 has affected the conduct of clinical trials worldwide. Once the health emergency began in Peru, the national government took measures to guarantee the conduct of COVID-19 clinical trials. A national research ethics committee was exclusively established for COVID-19 clinical trials; and a regulatory framework was implemented to ensure the ethical and timely conduct of these studies. To december 31, 2020, the Peruvian National Health Institute authorized 29 clinical trials, of which 4 test vaccines. The mean and standard deviation of time authorization were 19.3 and 10.5 days, respectively. 58.6% (n= 17) were phase II clinical trials and 34.5% (n= 10) were phase III; 31.0% (n= 9) were sponsored by a Peruvian institution. The aim of the actions implemented was to promote COVID-19 research while responding to the health emergency needs without affecting the protection of participants or the rigor of the studies.
Idioma originalEspañol
Páginas (desde-hasta)171-177
Número de páginas7
PublicaciónRevista Peruana de Medicina Experimental y Salud Publica
Volumen38
EstadoPublicada - 1 ene. 2021

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