Clinical Research of COVID-19 Based on Good Clinical Practices for Clinical Trials of Drugs

doi:10.19803/j.1672-8629.2021.02.01

Abstract

Abstract: Objective To review several issues arising from the current clinical trials of coronavirus disease 2019 (COVID-19) so as to promote subsequent trials and regulation. Methods In line with the new version of Good Clinical Practices for Clinical Trials of Drugs (2020 edition), the on-going COVID-19-related clinical trials were studied through an exhaustive literature search. Results The surge of COVID-19 related clinical trials had advanced our understanding of the characteristics and pathogenic mechanisms of SARS-CoV-2, and promoted the development of vaccines and drugs. However, many problems also arose, such as design flaws, waste of research resources, and regulatory difficulties. Conclusion The National Medical Products Administration (NMPA) and the National Health Commission (NHC) should draw on the experience of our own and other countries, solicit expert opinions and continue to optimize resource allocation. By promoting high-quality and high-efficiency clinical trials and nurturing professional clinical researchers, the national public health emergency management system will be improved substantially.

Key words: clinical trials, coronavirus disease 2019, good clinical practice

CLC Number:

R954.2

CONG Duanduan, ZHAO Fei, XUE Wei, LI Kexin, HU Xin. Clinical Research of COVID-19 Based on Good Clinical Practices for Clinical Trials of Drugs[J]. Chinese Journal of Pharmacovigilance, 2021, 18(2): 101-104.

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