Title
The regulation of COVID-19 clinical trials in Peru
Other title
La regulación de los ensayos clínicos para la COVID-19 en el Perú
Date Issued
01 January 2021
Access level
open access
Resource Type
journal article
Publisher(s)
Instituto Nacional de Salud
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.
Start page
171
End page
177
Volume
38
Issue
1
Language
Spanish
OCDE Knowledge area
Epidemiología
Salud pública, Salud ambiental
Subjects
Scopus EID
2-s2.0-85111789049
PubMed ID
Source
Revista Peruana de Medicina Experimental y Salud Publica
ISSN of the container
17264634
Sponsor(s)
El estudio fue financiado por el Instituto Nacional de Salud.
Sources of information:
Directorio de Producción Científica
Scopus