Single-arm phase II trial design under parametric cure models.

ABSTRACT: The current practice of designing single-arm phase II survival trials is limited under the exponential model. Trial design under the exponential model may not be appropriate when a portion of patients are cured. There is no literature available for designing single-arm phase II trials under the parametric cure model. In this paper, a test statistic is proposed, and a sample size formula is derived for designing single-arm phase II trials under a class of parametric cure models. Extensive simulations showed that the proposed test and sample size formula perform very well under different scenarios.

SUBMITTER: Wu J 

PROVIDER: S-EPMC4667689 | biostudies-literature | 2015 May-Jun

REPOSITORIES: biostudies-literature