Publications and further publicity

Publications

So far, five scientific publications came out of the SAVVY project.

• Stegherr, Beyersmann, et al. (2021): Statistical analysis plan, presenting the rationale and statistical concept of the empirical study conducted as part of the SAVVY project. The statistical methods are presented in unified notation and examples of their implementation in R and SAS are provided. arxiv | publication
• Stegherr, Schmoor, Lübbert, et al. (2021): Comparison of estimators via simulations. arxiv | publication
• Stegherr, Schmoor, Beyersmann, et al. (2021): 1-sample case, compares estimators of AE risk in one treatment arm. arxiv | publication
• Rufibach et al. (2023): 2-sample case, compares relative risk estimators comparing two treatment arms based on (1) AE probabilities and (2) hazards. arxiv | publication
• Rufibach et al. (2024): Overview paper, summarizing the above four papers and sketching a roadmap how to move forward with estimation of AE risks. arxiv | publication (open access).

Podcasts

Jan Beyersmann and Kaspar Rufibach have also been interviewed for two effective statistician podcasts discussing SAVVY:

• 7th July 2021: The analysis of adverse events done right – SAVVY.
• 29th November 2021: Effective statistician podcast (invited contribution to 200th episode). Invited contribution to the 200th episode of this podcast, featuring the contributors of the 10% most downloaded podcasts. Our contribution starts at 02:20:00.

References

Rufibach, K., J. Beyersmann, T. Friede, C. Schmoor, and R. Stegherr. 2024. “Survival Analysis for AdVerse Events with VarYing Follow-up Times (SAVVY): Summary of Findings and a Roadmap for the Future of Safety Analyses in Clinical Trials.” https://arxiv.org/abs/2402.17692.

Rufibach, K., R. Stegherr, C. Schmoor, V. Jehl, A. Allignol, A. Boeckenhoff, C. Dunger-Baldauf, et al. 2023. “Comparison of Adverse Event Risks in Randomized Controlled Trials with Varying Follow-up Times and Competing Events: Results from an Empirical Study.” Statistics in Biopharmaceutical Research 15 (4): 767–80. https://doi.org/10.1080/19466315.2022.2144944.

Stegherr, R., J. Beyersmann, V. Jehl, K. Rufibach, F. Leverkus, C. Schmoor, and T. Friede. 2021. “Survival Analysis for AdVerse Events with VarYing Follow-up Times (SAVVY): Rationale and Statistical Concept of a Meta-Analytic Study.” Biometrical Journal 63 (March): 650–70.

Stegherr, R., C. Schmoor, J. Beyersmann, K. Rufibach, V. Jehl, A. Brückner, L. Eisele, et al. 2021. “Survival analysis for AdVerse events with VarYing follow-up times (SAVVY)-estimation of adverse event risks.” Trials 22 (1): 420.

Stegherr, R., C. Schmoor, M. Lübbert, T. Friede, and J. Beyersmann. 2021. “Estimating and comparing adverse event probabilities in the presence of varying follow-up times and competing events.” Pharmaceutical Statistics 20 (6): 1125–46.