Bayesian design of a survival trial with a cured fraction using historical data.

ABSTRACT: In this paper, we develop a general Bayesian clinical trial design methodology, tailored for time-to-event trials with a cured fraction in scenarios where a previously completed clinical trial is available to inform the design and analysis of the new trial. Our methodology provides a conceptually appealing and computationally feasible framework that allows one to construct a fixed, maximally informative prior a priori while simultaneously identifying the minimum sample size required for the new trial so that the design has high power and reasonable type I error control from a Bayesian perspective. This strategy is particularly well suited for scenarios where adaptive borrowing approaches are not practical due to the nature of the trial, complexity of the model, or the source of the prior i

SUBMITTER: Psioda MA 

PROVIDER: S-EPMC6288795 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature