Track 10: Statistics, Evidence Generation and Real-World Data

This track focuses on the methodological and statistical approaches used to design, analyze, and interpret data for regulatory, health technology assessment (HTA), and clinical decision-making. It emphasizes innovative statistical methods, real-world data (RWD) study designs, causal inference, and benefit–risk quantification to strengthen the credibility of evidence across the drug development lifecycle. While Track 3 focuses on the generation, curation, integration, and operational enablement of data, Track 10 addresses the frameworks and analytical strategies that transform those data into actionable evidence. Sessions will highlight statistical innovation, effective communication of results, and cross-disciplinary collaboration to support regulatory submissions and HTA evaluations.