Part 2: Real-World Study Design, Methods and Use Cases

Real-world evidence (RWE) studies have become essential in supplementing evidence from randomized controlled trials (RCTs), especially when RCTs are infeasible, too costly, or lack applicability to broader patient populations.

This session, the second part of our “Real-World Study Design” series provides an in-depth guide to designing, implementing, and evaluating real-world studies. Join our expert speakers as they explore the methodologies, study designs, and practical considerations for leveraging RWE to assess the comparative effectiveness and safety of medications, supported by practical case examples.

Led by Michael Forstner, Senior VP of Pharmacoepidemiology and Risk Management, Maartje Smulders, Senior Director of Pharmacoepidemiology, and Alex Artyomenko, Head of RWE and Late Phase Division, this session is ideal for stakeholders in drug safety, clinical research, and regulatory affairs who are interested in applying real-world study designs to answer critical clinical questions.

Key Takeaways Include:

• Guidance on selecting the optimal real-world study design using a decision-making algorithm
• Solutions to methodological challenges unique to real-world studies and their practical application
• Insights from case studies demonstrating real-world study designs in action