La regulación de los ensayos clínicos para la COVID-19 en el Perú

Paula Cahuina Lope; Sarah Carracedo; Franco Romani

doi:10.17843/rpmesp.2021.381.6627

Authors

Paula Cahuina Lope Oficina General de Investigación y Transferencia Tecnológica, Instituto Nacional de Salud, Lima, Perú.Médico Cirujano, Especialista en Medicina Familiar y Comunitaria https://orcid.org/0000-0002-1259-557X
Sarah Carracedo Pontificia Universidad Católica del Perú, Lima, Perú. abogada, magíster en Bioética https://orcid.org/0000-0002-3995-6793
Franco Romani Oficina General de Investigación y Transferencia Tecnológica, Instituto Nacional de Salud, Lima, Perú. médico cirujano, magister en Epidemiología https://orcid.org/0000-0002-6471-5684

DOI:

https://doi.org/10.17843/rpmesp.2021.381.6627

Keywords:

COVID-19, Clinical Trials as Topic, Coronavirus Infections, Peru, Government Regulation

Abstract

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.