Additional Information

Optimal planning when assuming a prior distribution for the treatment effect can be done withe the help of the R package drugdevelopR (available at: https://github.com/Sterniii3/drugdevelopR) for programs

  • in the basic setting (Kirchner et al., 2016),
  • with multiple phase III trials (Erdmann et al., 2019a) or
  • with bias adjustment (Erdmann et al., 2019b)

References

Goette, H., Schueler, A., Kirchner, M., & Kieser, M. (2015). Sample size planning for phase II trials based on success probabilities for phase III. Pharmaceutical Statistics, 14(6), 515-524.

Kirchner, M., Kieser, M., Goette, H., & Schueler, A. (2016). Utility-based optimization of phase II/III programs. Statistics in Medicine, 35(2), 305-316.

Erdmann, S., Kieser, M., and Kirchner, M. (2019a). Optimal sample size allocation and go/no-go decision rules for phase II/III programs where several phase III trials are performed. Biometrical Journal, 61(2), 357-378.

Erdmann, S., Kirchner, M., Goette, H. & Kieser, M. (2019b). Optimal designs for phase II/III drug development programs including methods for discounting of phase II results. Submitted to peer-review journal.

Maintainer

Stella Erdmann, Institute of Medical Biometry, University of Heidelberg, email: Erdmann@imbi.uni-heidelberg.de.

Beta version 0.4

Additional Information

Optimal planning when assuming a prior distribution for the treatment effect can be done withe the help of the R package drugdevelopR (available at: https://github.com/Sterniii3/drugdevelopR).

Maintainer

Stella Erdmann, Institute of Medical Biometry, University of Heidelberg, email: Erdmann@imbi.uni-heidelberg.de.

Beta version 0.4

Additional Information

Optimal planning when assuming a prior distribution for the treatment effect can be done withe the help of the following R packages for programs

  • in the basic setting

References

Rufibach, K., Jordan, P., and Abt, M. (2016). Sequentially updating the likelihood of success of a Phase 3 pivotal time-to-event trial based on interim analyses or external information. Journal of Biopharmaceutical Statistics, 26(2), 191-201.

Maintainer

Stella Erdmann, Institute of Medical Biometry, University of Heidelberg, email: Erdmann@imbi.uni-heidelberg.de.

Beta version 0.4