Bayesian dose selection design for a binary outcome using restricted response adaptive randomization.

ABSTRACT:

Background

In phase II trials, the most efficacious dose is usually not known. Moreover, given limited resources, it is difficult to robustly identify a dose while also testing for a signal of efficacy that would support a phase III trial. Recent designs have sought to be more efficient by exploring multiple doses through the use of adaptive strategies. However, the added flexibility may potentially increase the risk of making incorrect assumptions and reduce the total amount of information available across the dose range as a function of imbalanced sample size.

Methods

To balance these challenges, a novel placebo-controlled design is presented in which a restricted Bayesian response adaptive randomization (RAR) is used to allocate a majority of subjects to the optimal dose

SUBMITTER: Meinzer C 

PROVIDER: S-EPMC5591573 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature