DTEBOP2: Bayesian Optimal Phase II Randomized Clinical Trial Design with Delayed Outcomes

Implements a Bayesian Optimal Phase II design (DTE-BOP2) for trials with delayed treatment effects, particularly relevant to immunotherapy studies where treatment benefits may emerge after a delay. The method builds upon the BOP2 framework and incorporates uncertainty in the delay timepoint through a truncated gamma prior, informed by expert knowledge or default settings. Supports two-arm trial designs with functionality for sample size determination, interim and final analyses, and comprehensive simulation under various delay and design scenarios. Ensures rigorous type I and II error control while improving trial efficiency and power when the delay effect is present. A manuscript describing the methodology is under development and will be formally referenced upon publication.

install.packages("DTEBOP2")

Try the DTEBOP2 package in your browser