論文

査読有り
2017年

Interim decision-making strategies in adaptive designs for population selection using time-to-event endpoints

JOURNAL OF BIOPHARMACEUTICAL STATISTICS
  • Ryuji Uozumi
  • ,
  • Chikuma Hamada

27
1
開始ページ
84
終了ページ
100
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1080/10543406.2016.1148714
出版者・発行元
TAYLOR & FRANCIS INC

Adaptive designs in oncology clinical trials with interim analyses for population selection could be used in the development of targeted therapies if a predefined biomarker hypothesis exists. In this article, we consider an interim analysis using overall survival (OS), progression-free survival (PFS), and both OS and PFS, to determine whether the whole population or only the biomarker-positive population should continue into the subsequent stage of the trial, whereas the final decision is made based on OS data only. In order to increase the probability of selecting the most appropriate population at the interim analysis, we propose an interim decision-making strategy in adaptive designs with correlated endpoints considering the post-progression survival (PPS) magnitudes. In our approach, the interim decision is made on the basis of predictive power by incorporating information on OS as well as PFS to supplement the incomplete OS data. Simulation studies assuming a targeted therapy demonstrated that our interim decision-making procedure performs well in terms of selecting the proper population, especially under a scenario in which PPS affects the correlation between OS and PFS.

リンク情報
DOI
https://doi.org/10.1080/10543406.2016.1148714
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000396555100007&DestApp=WOS_CPL
ID情報
  • DOI : 10.1080/10543406.2016.1148714
  • ISSN : 1054-3406
  • eISSN : 1520-5711
  • Web of Science ID : WOS:000396555100007

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