Operational experiences in China and statistical issues on the conduct of clinical trials during the COVID-19 pandemic

淡江大學機構典藏 > 理學院 > 應用數學與數據科學學系 > 期刊論文 > Item 987654321/122702

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题名:	Operational experiences in China and statistical issues on the conduct of clinical trials during the COVID-19 pandemic
作者:	Guo, Tong;Chen, Chian;Chiang, Chieh;Chen, Chi-Tian;Hsiao, Chin-Fu
关键词:	COVID-19;protocol modifications;remote data monitoring
日期:	2020-08-18
上传时间:	2022-05-09 12:10:39 (UTC+8)
摘要:	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.
關聯:	Statistics in Biopharmaceutical Research 12(4), p.438-442
DOI:	10.1080/19466315.2020.1797866
显示于类别:	[應用數學與數據科學學系] 期刊論文

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