教師資料查詢 | 類別: 期刊論文 | 教師: 姜 杰CHIANG, CHIEH (瀏覽個人網頁)

標題: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
語言英文
ISSN1946-6315
期刊性質國外
收錄於SCI;
產學合作
通訊作者
審稿制度
國別美國
公開徵稿
出版型式,電子版
相關連結
SDGs
Google+ 推薦功能,讓全世界都能看到您的推薦!