drugdevelopR-package: drugdevelopR: Utility-Based Optimal Phase II/III Drug...

In Sterniii3/drugdevelopR: Utility-Based Optimal Phase II/III Drug Development Planning

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

Description

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) \Sexpr[results=rd]{tools:::Rd_expr_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) \Sexpr[results=rd]{tools:::Rd_expr_doi("10.1186/s12874-020-01093-w")}), multiple phase III trials (Preussler et al. (2019) \Sexpr[results=rd]{tools:::Rd_expr_doi("10.1002/bimj.201700241")}), multi-arm trials (Preussler et al. (2019) \Sexpr[results=rd]{tools:::Rd_expr_doi("10.1080/19466315.2019.1702092")}), and multiple endpoints (Kieser et al. (2018) \Sexpr[results=rd]{tools:::Rd_expr_doi("10.1002/pst.1861")}).

Author(s)

Maintainer: Lukas D. Sauer [e-mail] (ORCID)

Authors:

• Stella Erdmann [e-mail]

• Johannes Cepicka

• Marietta Kirchner

• Meinhard Kieser

See Also

Useful links:

• https://github.com/Sterniii3/drugdevelopR

• https://sterniii3.github.io/drugdevelopR/

• Report bugs at https://github.com/Sterniii3/drugdevelopR/issues

Sterniii3/drugdevelopR documentation built on Jan. 14, 2025, 7:50 p.m.