BOP2FE - Bayesian Optimal Phase II Design with Futility and Efficacy
Stopping Boundaries
Bayesian optimal design with futility and efficacy
stopping boundaries (BOP2-FE) is a novel statistical framework
for single-arm Phase II clinical trials. It enables early
termination for efficacy when interim data are promising, while
explicitly controlling Type I and Type II error rates. The
design supports a variety of endpoint structures, including
single binary endpoints, nested endpoints, co-primary
endpoints, and joint monitoring of efficacy and toxicity. The
package provides tools for enumerating stopping boundaries
prior to trial initiation and for conducting simulation studies
to evaluate the design’s operating characteristics. Users can
flexibly specify design parameters to suit their specific
applications. For methodological details, refer to Xu et al.
(2025) <doi:10.1080/10543406.2025.2558142>.
