|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|
|Date Published||2014 May 30|
|Keywords||Algorithms, Clinical Trials, Phase II as Topic, Data Interpretation, Statistical, Disease-Free Survival, Humans, Research Design, Sample Size, Treatment Outcome|
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.
|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 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.