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

Bibliographic Data

ID15534285
AuthorsPaula Cahuina-Lope (0000-0002-1259-557X, Instituto Nacional de Salud, corresponding author), Sarah Carracedo (0000-0002-3995-6793, Pontificia Universidad Católica del Perú), Franco Romaní (0000-0002-6471-5684, Instituto Nacional de Salud)
Year2021
Volume38
Issue1
Pages171-7
Publication date2021-03-26
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueRevista Peruana de Medicina Experimental y Salud Pública (JOURNAL)
Journal identifiersISSN: 1726-4634 • E-ISSN: 1726-4642
PublisherNational Institute of Health of Peru (PUBLISHER • PE)
DOI10.17843/rpmesp.2021.381.6627
PMID34190912
OpenAlexW3134411171
LanguageES
Citations received1
References cited1

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

Coronavirus disease 2019 (COVID-19 · Humanities · Political science · Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 · Medicine · Philosophy · Public Health and Environmental Issues

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