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
Author(s)
CAHUINA LOPE, PAULA LORENA
Carracedo S.
ROMANI ROMANI, FRANCO RONALD
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
Salud pública, Salud ambiental
Epidemiología
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