Papers
- Bardo, M., Huber, C., Benda, N., Brugger, J., Fellinger, T., Galaune, V., Heinz, J., Heinzl, H., Hooker, A. C., Klinglmüller, F., König, F., Mathes, T., Mittlböck, M., Posch, M., Ristl, R., & Friede, T. (2023). Methods for non-proportional hazards in clinical trials: A systematic review. Statistical Methods in Medical Research. https://doi.org/10.1177/09622802241242325
- Klinglmüller, F., Fellinger, T., König, F., Friede, T., Hooker, A. C., Heinzl, H., Mittlböck, M., Brugger, J., Bardo, M., Huber, C., Benda, N., Posch, M., & Ristl, R. (2025). A Comparison of Statistical Methods for Time-To-Event Analyses in Randomized Controlled Trials Under Non-Proportional Hazards. http://dx.doi.org/10.1002/sim.70019
Study Protocols and Reports
- Report on the systematic literature review: Statistical analysis of trials where non proportional hazards are expected. (2022). [Techreport]. https://catalogues.ema.europa.eu/sites/default/files/document_files/Literature%20Review%20Rev.%202.pdf.
- Protocol: A Simulation Study to Evaluate the Performance Characteristics of Statistical Methods for the Analysis of Time-To-Event Data under Non-Proportional Hazards. (2022). [Techreport]. https://catalogues.ema.europa.eu/sites/default/files/document_files/2022-10-14%20CONFIRMS%20Simulation%20Study%20Protocol%20rev2.pdf.
- A Review of EMA Public Assessment Reports where Non-Proportional Hazards were Identified. (2024). [Techreport]. https://doi.org/10.48550/arXiv.2406.12492.
R-packages
- R-package: SimNPH: Simulate Non-Proportional Hazards. https://simnph.github.io/SimNPH/
- R-package: miniPCH: Survival Distributions with Piece-Wise Constant Hazards. https://simnph.github.io/miniPCH/
Simulation Results Shiny-App
- Shiny App for Visualisation of Simulation Scenarios and Results: https://simnph.github.io/SimResultsShinylive/about.html