Leveraging generative AI to transform statistical analysis plan authoring in clinical trials

Rogier Landman, Birol Emir, Richard Zhang, Giannis Manousaridis, Yi-Chien Lee, Lili Jiang, Gordon Siu, Feng Dai, Griffith Bell, Alexandra Thiry, Akhil Shekkari, Moumita Dasandhi, Amy Lauren Ashworth, Donal Nielson Gorman, Anna Plotka, Allison Wehr, Colombe Chappey, Subha Madhavan, Sheraz Khan

Clinical Trials: Journal of the Society for Clinical Trials

Published online on March 04, 2026

Abstract

Clinical Trials, Ahead of Print.
BackgroundStatistical analysis plans are critical regulatory documents that define the statistical methodology, objectives, and data-handling procedures for clinical trials. The traditional process of statistical analysis plan development is resource-...