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.


Reference manual

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install.packages("DTEBOP2")

1.0.3 by Zhongheng Cai, a year ago


Browse source code at https://github.com/cran/DTEBOP2


Authors: Zhongheng Cai [aut, cre] , Haitao Pan [aut]


Documentation:   PDF Manual  


GPL-3 license


Imports truncdist, doParallel, foreach, parallel, invgamma

Suggests knitr, rmarkdown, survRM2adapt, ggplot2, reconstructKM, survival, survminer


See at CRAN