Clinical trial simulations and Clinical Scenario Evaluation
Clinical trial simulations play a key role in developing efficient approaches to designing, conducting and analyzing trials, especially late-stage trials that utilize complex designs and analysis strategies where analytical evaluation approaches are typically not available. Thanks to simulations, trial sponsors can perform a comprehensive quantitative assessment of available options under a large number of treatment effect scenarios. Clinical Scenario Evaluation is an efficient quantitative approach to simulation-based evaluation of clinical trials that has found multiple applications across the biopharmaceutical industry.
Biopharmaceutical Software Working Group organized by the Biopharmaceutical Section of the American Statistical Association.
- Dmitrienko, A., Paux, G., Brechenmacher, T. (2016). Power calculations in clinical trials with complex clinical objectives. Journal of the Japanese Society of Computational Statistics. 28, 15-50.
- Dmitrienko, A., Paux, G., Pulkstenis, E., Zhang, J. (2016). Tradeoff-based optimization criteria in clinical trials with multiple objectives and adaptive designs. Journal of Biopharmaceutical Statistics. 26, 120-140.
- Dmitrienko, A., Pulkstenis, E. (editors). (2017). Clinical Trial Optimization Using R. Chapman and Hall/CRC Press, New York.
- Paux, G., Dmitrienko, A. (2018). Penalty-based approaches to evaluating multiplicity adjustments in clinical trials: Traditional multiplicity problems. Journal of Biopharmaceutical Statistics. 28, 146-168.
- Paux, G., Dmitrienko, A. (2018). Penalty-based approaches to evaluating multiplicity adjustments in clinical trials: Advanced multiplicity problems. Journal of Biopharmaceutical Statistics. 28, 169-188.
Mediana package (R package for general simulation-based power and sample size calculations in fixed-sample trials).
Mediana Designer (free Windows-based software tool for traditional and simulation-based power/sample size calculations in fixed-sample and group-sequential trials).