Optimal two-stage log-rank test for randomized phase II clinical trials.

Journal Article (Journal Article)

Randomized controlled clinical trials are conducted to determine whether a new treatment is safe and efficacious compared to a standard therapy. We consider randomized clinical trials with right censored time to event endpoint, called survival time here. The two-sample log-rank test is popularly used to test if the experimental therapy has a longer survival distribution than the control therapy or not. We consider an early stopping for futility only or for both futility and efficacy. For planning such clinical trials, this article presents two-stage designs that are optimal in the sense that either the maximal sample size or the expected sample size when the experimental therapy is futile or superior is minimized under the given type I and II error rates. Optimal designs for a range of design parameters are tabulated and evaluated using simulations.

Full Text

Duke Authors

Cited Authors

  • Kwak, M; Jung, S-H

Published Date

  • 2017

Published In

Volume / Issue

  • 27 / 4

Start / End Page

  • 639 - 658

PubMed ID

  • 27050043

Pubmed Central ID

  • PMC5292306

Electronic International Standard Serial Number (EISSN)

  • 1520-5711

Digital Object Identifier (DOI)

  • 10.1080/10543406.2016.1167073


  • eng

Conference Location

  • England