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Operational Experiences in China and Statistical Issues on the Conduct of Clinical Trials During the COVID-19 Pandemic #MMPMID34191976
Guo T; Chen C; Chiang C; Chen CT; Hsiao CF
Stat Biopharm Res 2020[Aug]; 12 (4): 438-442 PMID34191976show ga
The COVID-19 outbreak is impacting clinical trials in many ways, such as patient recruitment, data collection and data analysis. To proceed in this difficult time, the adoption of new technologies and new approaches for conducting clinical trials needs to be accelerated. Simultaneously, regulatory agencies such as the US FDA and EMA have issued guidance to help the pharmaceutical industry conduct clinical trials of medical products during the COVID-19 pandemic. In this article, we will address some statistical issues and operational experiences in the conduction of clinical trials during the COVID-19 pandemic. Specifically, we will share experiences in the applications of remote clinical trials in China. Statistical issues related to protocol modifications caused by COVID-19 will be raised.