國家衛生研究院 NHRI:Item 3990099045/10819

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Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/10819

Title:	Efficient group-sequential designs for monitoring two time-to-event outcomes in clinical trials
Authors:	Hamasaki, T;Asakura, K;Sugimoto, T;Evans, SR;Yamamoto, H;Hsiao, CF
Contributors:	Institute of Population Health Sciences
Abstract:	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.
Date:	2017-05
Relation:	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
Appears in Collections:	[Chin-Fu Hsiao] Conference Papers/Meeting Abstract

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