國家衛生研究院 NHRI:Item 3990099045/16053
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    题名: Establishing and using threshold of surrogate endpoint in relation to clinical endpoint
    作者: Cheng, YC;Tsou, HH;Hung, HMJ;Fan, B;Fan, B
    贡献者: Institute of Population Health Sciences
    摘要: Clinical trials are an essential aspect of the drug development process. Clinical endpoints and surrogate endpoints are two terms used in clinical trials to measure the effectiveness of a treatment. While clinical endpoints typically require higher costs and longer durations of observation to show direct clinical benefits, surrogate endpoints have been introduced as a cheaper and faster method that may be used to predict clinical effects. When there is a linear relationship between the surrogate and the clinical endpoint, the surrogate may still need to rule out a threshold that corresponds to no clinical benefit. The determination of such a threshold uses the knowledge of numerous parameters in the bivariate statistical distribution of the clinical response and the surrogate. In our work, we present a concept of “working” threshold to incorporate statistical uncertainties in determination of such a threshold.
    日期: 2024-08-28
    關聯: Statistics in Biopharmaceutical Research. 2024 Aug 28;Article in Press.
    Link to: https://doi.org/10.1080/19466315.2024.2370405
    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:001299612800001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85202759497
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