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10.17843/rpmesp.2021.381.6627

http://scihub22266oqcxt.onion/10.17843/rpmesp.2021.381.6627
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suck abstract from ncbi


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pmid34190912      Rev+Peru+Med+Exp+Salud+Publica 2021 ; 38 (1): 171-177
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  • La regulacion de los ensayos clinicos para la COVID-19 en el Peru #MMPMID34190912
  • Lope PC; Carracedo S; Romani F
  • Rev Peru Med Exp Salud Publica 2021[Jan]; 38 (1): 171-177 PMID34190912show ga
  • 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.
  • |*COVID-19[MESH]
  • |Ethics Committees, Research[MESH]
  • |Humans[MESH]
  • |Peru[MESH]


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