As innovative clinical trial designs gain traction, sponsors are looking more closely at how real-world data can be used to strengthen evidence generation without compromising rigor. Clearer regulatory guidance, improved data access, and advances in analytics are opening the door to more sophisticated approaches, but only when RWD is applied with intent and discipline.
In a new Pharma Exec article, Billy Amzal, Head of Strategic Consulting at Phastar, explores how RWD can be used effectively across modern trial designs. Drawing on practical examples, he examines the role of synthetic patients and in-silico cohorts, from emulation and simulation to generative AI, and considers what these approaches mean for trial acceleration, long-term outcome projection, and regulatory and HTA decision-making.