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

TitleOptimal two-stage log-rank test for randomized phase II clinical trials.
Publication TypeJournal Article
Year of Publication2017
AuthorsKwak, Minjung, and Sin-Ho Jung
JournalJ Biopharm Stat
Volume27
Issue4
Pagination639-658
Date Published2017
ISSN1520-5711
KeywordsClinical Trials, Phase II as Topic, Data Interpretation, Statistical, Humans, Medical Futility, Randomized Controlled Trials as Topic, Research Design, Sample Size, Survival Rate
Abstract

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.

DOI10.1080/10543406.2016.1167073
Alternate JournalJ Biopharm Stat
Original PublicationOptimal two-stage log-rank test for randomized phase II clinical trials.
PubMed ID27050043
PubMed Central IDPMC5292306
Grant ListP01 CA142538 / CA / NCI NIH HHS / United States