Bayesian Optimal Phase II Randomized Clinical Trial Design with Delayed Outcomes
Compute Weighted Least Squares Error (Internal)
Computes the hazard ratio between post- and pre-separation periods, pr...
Return expected event number at interim analysis and final analysis.
Generate event times from a piecewise exponential distribution.
Obtain Optimal Design Parameters for DTE-BOP2 Design
Compute Operating Characteristics for Two-Arm Piecewise Exponential De...
Generate Random Variables from a Truncated Gamma Distribution.
Estimate Shape and Scale Parameters for Truncated Gamma Distribution
Compute the Total Time-on-Test (TTOT) Statistic
Calculate Sample Sizes for a Two-Stage Trial Design.
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.