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

Qingshu Lu, Shein Chung Chow, Siu Keung Tse, Yun-Chan Chi, Lan Yan Yang

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)311-323
Number of pages13
JournalJournal of Biopharmaceutical Statistics
Volume19
Issue number2
DOIs
Publication statusPublished - 2009 Mar 1

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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