國家衛生研究院 NHRI:Item 3990099045/12901
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/12901


    Title: Operational experiences in China and statistical issues on the conduct of clinical trials during the COVID-19 pandemic
    Authors: Guo, T;Chen, C;Chiang, C;Chen, CT;Hsiao, CF
    Contributors: Institute of Population Health Sciences
    Abstract: 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 to 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.
    Date: 2020-10
    Relation: Statistics in Biopharmaceutical Research. 2020 Oct;12(4):438-442.
    Link to: http://dx.doi.org/10.1080/19466315.2020.1797866
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1946-6315&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000562032200001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85089601222
    Appears in Collections:[Chin-Fu Hsiao] Periodical Articles

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