Utility-Based Optimal Phase II/III Drug Development Planning
Overview
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).
Improvements that will work with the Shiny apps:
- Adding trace to all
optimal_*()functions.
From NEWS.md in the release
Install
Health
- OK13 OK2026-08-05
- NOTE12 OK, 1 NOTE2026-08-01
- OK14 OK2026-03-10
Documentation
- Help pages
- 92 (78 internal)includes a package overview page
- Examples that run
- 62%39 run in a plain check · 24 only when donttest examples are enabled (R CMD check --as-cran)
- Exported functions with examples
- 79%
- Documented parameters
- 100%
- Return-value docs
- 99%
- Help pages citing references
- 16%
- Bias adjustment - methods for discounting of phase II results HTML
- Binary outcome variables HTML
- Fixed effect estimates and prior distributions HTML
- Interpreting the rest of the output HTML
- Introduction to planning phase II and phase III trials with drugdevelopR HTML
- More parameters to adapt to specific settings HTML
- Multiarm - methods for multi-arm programs HTML
- Multiple - methods for trials with multiple endpoints HTML
- Multitrial - methods for programs with several phase III trials HTML
- Package validation HTML
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Repository
- PRs merged (all time)
- 100%
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- Median days to close, 50 most recently updated closed PRs
- 0
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8 development-tooling and community-health practices detected across 4 families in the upstream repository
Checks run against github.com/sterniii3/drugdevelopr on 2026-10-11.
The R CMD check workflow runs on Linux
GitHub Pages site last deployed 2025-01-14 · The repository has a site deploy workflow
pkgdown site last built 2025-01-14
Dependencies
Installing drugdevelopR adds 20 packages (12 with compiled code, 12 MB of source tarballs). Heaviest: cubature 3.2 MB, Rcpp 1.8 MB, mvtnorm 1.0 MB.
Code & Tests
People & History
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- RR 4.6.0 released · 2026-04-24
- RR 4.5.0 released · 2025-04-11
- 1.0.2Latest
- RR 4.4.0 released · 2024-04-24
- 1.0.12024-01-10
- RR 4.3.0 released · 2023-04-21
Package metadata
- First published
- 2024-01-10
- Total releases
- 2 / 2 yrs
- License
- MIT + file LICENSE OSI
- Minimum R
- ≥ 3.5.0
- Download size
- 284 KB
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