國家衛生研究院 NHRI:Item 3990099045/10819
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    题名: Efficient group-sequential designs for monitoring two time-to-event outcomes in clinical trials
    作者: Hamasaki, T;Asakura, K;Sugimoto, T;Evans, SR;Yamamoto, H;Hsiao, CF
    贡献者: Institute of Population Health Sciences
    摘要: We discuss logrank test-based methods for early efficacy or futility evaluation in group-sequential clinical trials designed to compare two interventions using two time-to-event outcomes. We consider three typical situations (1) both events are non-composite and nonfatal, (2) both events are non-composite but one event is fatal, and (3) one event is composite but other is fatal and non-composite. We outline strategies for rejecting the null hypothesis associated with two inferential goals, evaluating if a test intervention is superior to a control intervention on: (1) both outcomes (multiple co-primary endpoints: MCPE), and (2) at least one outcome (multiple primary endpoints: MPE). We provide an example to illustrate the methods and discuss practical considerations when designing these trials.
    日期: 2017-05
    關聯: Trials. 2017 May;18(Suppl. 1):Meeting Abstract P36.
    Link to: https://doi.org/10.1186/s13063-017-1902-y
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1745-6215&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000410814200036
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