Application of Bayesian predictive probability for interim futility analysis in single-arm phase II trial.

ABSTRACT:

Background

Bayesian predictive probability design, with a binary endpoint, is gaining attention for the phase II trial due to its innovative strategy. To make the Bayesian design more accessible, we elucidate this Bayesian approach with a R package to streamline a statistical plan, so biostatisticians and clinicians can easily integrate the design into clinical trial.

Methods

We utilize a Bayesian framework using Bayesian posterior probability and predictive probability to build a R package and develop a statistical plan for the trial design. With pre-defined sample sizes, the approach employs the posterior probability with a threshold to calculate the minimum number of responders needed at end of the study to claim efficacy. Then the predictive probability is applied to eva

SUBMITTER: Chen DT 

PROVIDER: S-EPMC6711387 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature