MedianaDesigner-package: Efficient Simulation-Based Power and Sample Size Calculations...

Description Details Author(s) References

Description

The MedianaDesigner package provides efficient simulation-based power and sample size calculations for a broad class of late-stage clinical trials, including Phase II trials, seamless Phase II/III trials and Phase III trials:

For more information on this package, visit https://mediana.us/free-software/. The technical manuals with a detailed description of the statistical methodology implemented in each module are available at https://medianasoft.github.io/MedianaDesigner. Additional information and multiple case studies can be found in the online manual at https://medianasoft.github.io/MedianaDesigner.

Details

Package: MedianaDesigner
Type: Package
Version: 0.4
Date: 2021-10-15
License: GPL-3

Key functions included in the package:

The package comes with one example data set:

Multiple case studies are included in this vignette to illustrate the use of this package for designing clinical trials with data-driven design elements:

Author(s)

Mediana (www.mediana.us). We would like to thank multiple individuals, including Thomas Brechenmacher (IQVIA), Douglas McNair (Gates Foundation) and Thomas Peppard (Certara), for their feedback that helped us improve the package and add new features.

References

Alosh, M., Bretz, F., Huque, M. (2014). Advanced multiplicity adjustment methods in clinical trials. Statistics in Medicine. 33, 693-713.

Bagiella, E., Heitjan, D.F. (2001). Predicting analysis times in randomized clinical trials. Statistics in Medicine. 20, 2055-2063.

Chuang-Stein, C., Kirby, S., French, J., Kowalski, K., Marshall, S., Smith, M. K. (2011). A quantitative approach for making go/no-go decisions in drug development. Drug Information Journal. 45, 187-202.

Dmitrienko, A., Bretz, F., Westfall, P.H., et al. (2009). Multiple testing methodology. Multiple testing problems in pharmaceutical statistics. Dmitrienko, A., Tamhane, A.C., Bretz, F. (editors). New York: Chapman and Hall/CRC Press.

Dmitrienko, A., Tamhane, A.C. (2011). Mixtures of multiple testing procedures for gatekeeping applications in clinical trials. Statistics in Medicine. 30, 1473-1488.

Dmitrienko, A., D'Agostino, R. Sr. (2013). Traditional multiplicity adjustment methods in clinical trials. Statistics in Medicine. 32, 5172-5218.

Dmitrienko, A., Kordzakhia, G., Brechenmacher, T. (2016). Mixture-based gatekeeping procedures for multiplicity problems with multiple sequences of hypotheses. Journal of Biopharmaceutical Statistics. 26, 758-780.

Dmitrienko, A., Paux, G. (2017). Subgroup analysis in clinical trials. Clinical Trial Optimization Using R. Dmitrienko, A., Pulkstenis, E. (editors). Chapman and Hall/CRC Press, New York.

Dmitrienko, A., D'Agostino, R.B. (2018). Multiplicity considerations in clinical trials. New England Journal of Medicine. 378, 2115-2122.

Herson, J. (1979). Predictive probability early termination plans for Phase II clinical trials. Biometrics. 35, 775-783.

Kordzakhia, G., Brechenmacher, T., Ishida, E., Dmitrienko, A., Zheng, W.W., Lie, D.F. (2018). An enhanced mixture method for constructing gatekeeping procedures in clinical trials. Journal of Biopharmaceutical Statistics. 28, 113-128.

Millen, B., Dmitrienko, A., Ruberg, S., Shen, L. (2012). A statistical framework for decision making in confirmatory multi-population tailoring clinical trials. Drug Information Journal. 46, 647-656.

Wang, D., Cui, L., Zhang, L., Yang, B. (2014). An ROC approach to evaluate interim go/no-go decision-making quality with application to futility stopping in the clinical trial designs. New Developments in Statistical Modeling, Inference and Application. Jin, Z., Liu, M., Luo, X. (editors). Springer, New York. 121-147.

Wassmer, G., Brannath, W. (2016). Group Sequential and Confirmatory Adaptive Designs in Clinical Trials. New York: Springer.


MedianaDesigner documentation built on Oct. 11, 2021, 9:10 a.m.