Abstract

LOPE, Paula Cahuina; CARRACEDO, Sarah  and  ROMANI, Franco. The regulation of COVID-19 clinical trials in Peru. Rev. perú. med. exp. salud publica [online]. 2021, vol.38, n.1, pp.171-177.  Epub Feb 10, 2021. ISSN 1726-4634.  http://dx.doi.org/10.17843/rpmesp.2021.381.6627.

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.

Keywords : COVID-19; Clinical Trials as Topic; Coronavirus Infections; Peru; Government Regulation.

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