Flexible Bayesian subgroup analysis in early and confirmatory trials

Subgroup analysis is one of the most important issues in clinical trials. In confirmatory trials, it is critical to investigate consistency of the treatment effect across subgroups, which could potentially result in incorrect scientific conclusion or regulatory decision. There are many challenges and methodological complications of interpreting subgroup results beyond the regulatory setting. For the early phase or proof of concept trials, particularly in basket trials, it is also important to have reliable estimation of subgroup treatment effect in order to guide the next phase go/no-go decision making when large biases can be introduced due to small sample size or random variability.

Source: Contemporary Clinical Trials - September 13, 2020 Category: Radiology Authors: Veronica Bunn, Rachael Liu, Junjing Lin, Jianchang Lin Source Type: research