Sample size calculation for the log-rank tests for multi-arm trials with a control


Journal Article

Suppose that there are K experimental arms and a control arm in a study with survival as the primary endpoint. We consider a Dunnett-type testing procedure to discover the experimental arms that have longer survival distributions than the control arm using the log-rank statistic. In order to adjust for the multiplicity of the testing procedure, a Dunnett-type test controls the family-wise error rate (FWER). We derive the sample size required for a given parameter setting on the FWER level, power, survival distributions of the K + 1 arms, accrual period (or accrual rate), and additional follow-up period. Through simulations, derived sample sizes are shown to accurately maintain the power. The proposed method is applied to a real clinical trial. © 2008 Elsevier Ltd. All rights reserved.

Full Text

Duke Authors

Cited Authors

  • Jung, SH; Kim, C; Chow, SC

Published Date

  • March 1, 2008

Published In

Volume / Issue

  • 37 / 1

Start / End Page

  • 11 - 22

International Standard Serial Number (ISSN)

  • 1226-3192

Digital Object Identifier (DOI)

  • 10.1016/j.jkss.2007.11.001

Citation Source

  • Scopus