Sample size estimation based on event data for a two-stage survival adaptive trial with different durations

Research output: Journal Publications and Reviews (RGC: 21, 22, 62)21_Publication in refereed journalpeer-review

8 Scopus Citations
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Detail(s)

Original languageEnglish
Pages (from-to)311-323
Journal / PublicationJournal of Biopharmaceutical Statistics
Volume19
Issue number2
Publication statusPublished - Mar 2009

Abstract

In clinical development, an adaptive design combining results from two separate studies (e.g., a seamless adaptive design with a dose finding study phase and a confirmatory study phase) is commonly considered. The purpose of an adaptive design is not only to reduce lead time between the two studies, but also to evaluate the treatment effect in a more efficient way. In this paper, the focus is on the case where the study objectives are the same but the time durations of the study periods are different in the two stages. In particular, event data are collected in both stages. Statistical procedure for combining data observed from the two different stages is discussed. Furthermore, results on hypotheses testing and sample size calculation are derived for the comparison of two treatments. Copyright © Taylor & Francis Group, LLC.

Research Area(s)

  • Biomarker, Event data, Exponential distribution, Sample size determination, Two-stage adaptive design

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