Bridging the Evidence Gap: Integrating Real-World Data With Randomized Controlled Trials

PURPOSE: This workshop will explore how integrating Real-World Data (RWD)—such as registry data and other observational sources—with data from Randomized Controlled Trials (RCTs) can address critical research and regulatory questions that RCTs alone cannot answer. Combining these complementary data sources enables researchers to generate deeper insights into treatment effectiveness, expand findings to broader patient populations, and improve decision-making across diverse settings. DESCRIPTION: This workshop will feature dynamic, short-format illustrations of how merging RWD with RCT data can overcome traditional trial limitations and enhance evidence generation. Presentations will highlight diverse RWD from the USA and the Nordics, demonstrating how global data sources can enrich insights and applicability across populations. Ms. Grip will present on creating external control arms to generate critical additional evidence for RCTs, focusing on a cytarabine trial in acute myeloid leukemia linked with high-quality RWD (10 min). Dr. Young will discuss methods for integrating RWD with RCTs to extend trial results to real-world populations, illustrated by a case study on anticoagulation during percutaneous coronary intervention (10 min). Dr. Dixon will share practical considerations for planning, designing, and executing external control arms, drawing on industry experience across multiple therapeutic areas. (10 min).Dr. Ritchey will conclude the session with a 30-minute interactive discussion and Q&A. To foster engagement, interactive polling will capture audience perspectives, guide the conversation, and prioritize topics in real time. This approach will provide participants the opportunity to contribute their insights and directly shape the discussion. This symposium will be valuable to researchers, regulators, and industry professionals seeking to leverage integrated data to address complex research questions and improve regulatory decision-making.