The regulation of COVID-19 clinical trials in Peru

Authors

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.

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Published

2021-02-10

Issue

Section

Special Section

How to Cite

1.
Cahuina Lope P, Carracedo S, Romani F. The regulation of COVID-19 clinical trials in Peru. Rev Peru Med Exp Salud Publica [Internet]. 2021 Feb. 10 [cited 2024 May 23];38(1):171-7. Available from: https://rpmesp.ins.gob.pe/index.php/rpmesp/article/view/6627