drugdevelopR
CRANdrugdevelopRMaRDI QIDQ5978238FDOQ5978238
Utility-Based Optimal Phase II/III Drug Development Planning
Johannes Cepicka, Stella Erdmann, Marietta Kirchner, Lukas D. Sauer, Meinhard Kieser
Last update: 10 January 2024
Copyright license: MIT license, File License
Software version identifier: 1.0.1
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>).
- Optimal sample size allocation and go/no‐go decision rules for phase II/III programs where several phase III trials are performed
- Utility‐based optimization of phase II/III programs
- Optimal designs for phase II/III drug development programs including methods for discounting of phase II results
- Optimal Designs for Multi-Arm Phase II/III Drug Development Programs
- Optimal planning of phase II/III programs for clinical trials with multiple endpoints
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