Operational experiences in China and statistical issues on the conduct of clinical trials during the COVID-19 pandemic
學年 109
學期 1
出版（發表）日期 2020-08-18
作品名稱 Operational experiences in China and statistical issues on the conduct of clinical trials during the COVID-19 pandemic
作品名稱（其他語言）
著者 Tong Guo; Chian Chen; Chieh Chiang; Chi-Tian Chen; Chin-Fu Hsiao
單位
出版者
著錄名稱、卷期、頁數 Statistics in Biopharmaceutical Research 12(4), p.438-442
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.
關鍵字 COVID-19;protocol modifications;remote data monitoring
語言 en
ISSN 1946-6315
期刊性質 國外
收錄於 SCI
產學合作
通訊作者
審稿制度 否
國別 USA
公開徵稿
出版型式 ,電子版
相關連結

機構典藏連結 ( http://tkuir.lib.tku.edu.tw:8080/dspace/handle/987654321/122702 )