Sterniii3/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>).
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Package details |
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| Author | Stella Erdmann [aut], Johannes Cepicka [aut], Marietta Kirchner [aut], Meinhard Kieser [aut], Lukas D. Sauer [aut, cre] (<https://orcid.org/0000-0002-1340-9994>) |
| Maintainer | Lukas D. Sauer <sauer@imbi.uni-heidelberg.de> |
| License | MIT + file LICENSE |
| Version | 1.0.1 |
| URL | https://github.com/Sterniii3/drugdevelopR https://sterniii3.github.io/drugdevelopR/ |
| Package repository | View on GitHub |
| Installation |
Install the latest version of this package by entering the following in R:
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