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.

Version:	1.0.3
Depends:	R (≥ 3.5.0)
Imports:	truncdist, doParallel, foreach, parallel, invgamma
Suggests:	knitr, rmarkdown, survRM2adapt, ggplot2, reconstructKM, survival, survminer
Published:	2025-05-09
DOI:	10.32614/CRAN.package.DTEBOP2
Author:	Zhongheng Cai [aut, cre], Haitao Pan [aut]
Maintainer:	Zhongheng Cai <zhonghengcai123 at gmail.com>
License:	GPL-3
NeedsCompilation:	no
CRAN checks:	DTEBOP2 results

Documentation:

Reference manual:	DTEBOP2.pdf
Vignettes:	DTEBOP2 (source, R code)

Downloads:

Package source:	DTEBOP2_1.0.3.tar.gz
Windows binaries:	r-devel: DTEBOP2_1.0.3.zip, r-release: DTEBOP2_1.0.3.zip, r-oldrel: not available
macOS binaries:	r-release (arm64): DTEBOP2_1.0.3.tgz, r-oldrel (arm64): DTEBOP2_1.0.3.tgz, r-release (x86_64): DTEBOP2_1.0.3.tgz, r-oldrel (x86_64): DTEBOP2_1.0.3.tgz

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