Title | Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test. |
Publication Type | Journal Article |
Year of Publication | 2014 |
Authors | Kwak, Minjung, and Sin-Ho Jung |
Journal | Stat Med |
Volume | 33 |
Issue | 12 |
Pagination | 2004-16 |
Date Published | 2014 May 30 |
ISSN | 1097-0258 |
Keywords | Algorithms, Clinical Trials, Phase II as Topic, Data Interpretation, Statistical, Disease-Free Survival, Humans, Research Design, Sample Size, Treatment Outcome |
Abstract | Phase II clinical trials are often conducted to determine whether a new treatment is sufficiently promising to warrant a major controlled clinical evaluation against a standard therapy. We consider single-arm phase II clinical trials with right censored survival time responses where the ordinary one-sample logrank test is commonly used for testing the treatment efficacy. For planning such clinical trials, this paper presents two-stage designs that are optimal in the sense that the expected sample size is minimized if the new regimen has low efficacy subject to constraints of the type I and type II errors. Two-stage designs, which minimize the maximal sample size, are also determined. Optimal and minimax designs for a range of design parameters are tabulated along with examples. |
DOI | 10.1002/sim.6073 |
Alternate Journal | Stat Med |
Original Publication | Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test. |
PubMed ID | 24338995 |
PubMed Central ID | PMC4013236 |
Grant List | P01 CA142538 / CA / NCI NIH HHS / United States CA142538-01 / CA / NCI NIH HHS / United States |
Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test.
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