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


Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Lu, Q; Chow, SC; Tse, SK; Chi, Y; Yang, LY

Published Date

  • 2009

Published In

Volume / Issue

  • 19 / 2

Start / End Page

  • 311 - 323

PubMed ID

  • 19212882

Pubmed Central ID

  • 19212882

Electronic International Standard Serial Number (EISSN)

  • 1520-5711

Digital Object Identifier (DOI)

  • 10.1080/10543400802622527


  • eng

Conference Location

  • England