drugdevelopR: Utility-Based Optimal Phase II/III Drug Development Planning

Plan optimal sample size allocation and go/no-go decision rules for phase II/III drug development programs with time-to-event, binary or normally distributed endpoints when assuming fixed treatment effects or a prior distribution for the treatment effect, using methods from Kirchner et al. (2016) <doi:10.1002/sim.6624> and Preussler (2020). Optimal is in the sense of maximal expected utility, where the utility is a function taking into account the expected cost and benefit of the program. It is possible to extend to more complex settings with bias correction (Preussler S et al. (2020) <doi:10.1186/s12874-020-01093-w>), multiple phase III trials (Preussler et al. (2019) <doi:10.1002/bimj.201700241>), multi-arm trials (Preussler et al. (2019) <doi:10.1080/19466315.2019.1702092>), and multiple endpoints (Kieser et al. (2018) <doi:10.1002/pst.1861>).

Version:	1.0.2
Depends:	R (≥ 3.5.0), doParallel, parallel, foreach, iterators
Imports:	mvtnorm, cubature, msm, MASS, stats, progressr
Suggests:	rmarkdown, knitr, testthat (≥ 3.0.0), covr, kableExtra, magrittr, devtools
Published:	2025-01-14
DOI:	10.32614/CRAN.package.drugdevelopR
Author:	Stella Erdmann [aut], Johannes Cepicka [aut], Marietta Kirchner [aut], Meinhard Kieser [aut], Lukas D. Sauer [aut, cre]
Maintainer:	Lukas D. Sauer <sauer at imbi.uni-heidelberg.de>
BugReports:	https://github.com/Sterniii3/drugdevelopR/issues
License:	MIT + file LICENSE
URL:	https://github.com/Sterniii3/drugdevelopR, https://sterniii3.github.io/drugdevelopR/
NeedsCompilation:	no
Materials:	README NEWS
CRAN checks:	drugdevelopR results

Documentation:

Reference manual:

drugdevelopR.pdf

Vignettes:

Bias adjustment - methods for discounting of phase II results (source, R code) Binary outcome variables (source, R code) Fixed effect estimates and prior distributions (source, R code) Interpreting the rest of the output (source, R code) Introduction to planning phase II and phase III trials with drugdevelopR (source, R code) More parameters to adapt to specific settings (source, R code) Multiarm - methods for multi-arm programs (source, R code) Multiple - methods for trials with multiple endpoints (source, R code) Multitrial - methods for programs with several phase III trials (source, R code) Package validation (source, R code) Time-to-event outcome variables (source, R code)

Downloads:

Package source:	drugdevelopR_1.0.2.tar.gz
Windows binaries:	r-devel: drugdevelopR_1.0.1.zip, r-release: drugdevelopR_1.0.1.zip, r-oldrel: drugdevelopR_1.0.2.zip
macOS binaries:	r-release (arm64): drugdevelopR_1.0.2.tgz, r-oldrel (arm64): drugdevelopR_1.0.2.tgz, r-release (x86_64): drugdevelopR_1.0.2.tgz, r-oldrel (x86_64): drugdevelopR_1.0.2.tgz
Old sources:	drugdevelopR archive

Linking:

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