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: 1.0.1
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: 2024-01-10
Author: Stella Erdmann [aut], Johannes Cepicka [aut], Marietta Kirchner [aut], Meinhard Kieser [aut], Lukas D. Sauer ORCID iD [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
Binary outcome variables
Fixed effect estimates and prior distributions
Interpreting the rest of the output
Introduction to planning phase II and phase III trials with drugdevelopR
More parameters to adapt to specific settings
Multiarm - methods for multi-arm programs
Multiple - methods for trials with multiple endpoints
Multitrial - methods for programs with several phase III trials
Package validation
Time-to-event outcome variables

Downloads:

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

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