2025 RISW Workshop Takeaways: Workshop Sheds Light On Important Statistical Advances For The Biopharma Industry

By Lin Li and Lira Pi, Cencora

The 2025 Regulatory-Industry Statistics Workshop (RISW) highlighted a pivotal shift toward integrating artificial intelligence with traditional statistical frameworks to streamline drug development. By combining machine learning with causal inference, researchers can now rigorously leverage external data sources, such as natural history and real-world evidence. This synergy is particularly vital for rare disease trials where traditional control groups are often unfeasible. Furthermore, Bayesian adaptive designs are proving essential for maintaining statistical power while reducing sample sizes and trial durations.

These advancements, discussed extensively at RISW, offer a clear path toward more efficient, data-driven regulatory submissions. To understand how these evolving methodologies are shaping the future of clinical evidence, read the full insights from the workshop sessions.