The evolving landscape of evidence generation in healthcare, including the growing use of large patient registries and the introduction of real-world evidence (RWE) standards by regulatory agencies, has underscored the importance of integrating non-randomized studies (NRS) with randomized controlled trials (RCTs) in healthcare decision-making. While NRS offer valuable insights into the real-world performance of therapeutic interventions—particularly when RCTs are impractical or lack generalizability—the absence of clear methodological frameworks for synthesizing evidence from these sources has limited their acceptance in practice.

In this webinar, experts from the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research Special Interest Group will present a newly developed, ISPE-endorsed 7-step framework for the trustworthy integration of evidence from RCTs and NRS. Moderated by Dr. Elisabetta Patorno, the session will begin with an introduction to the challenges and opportunities in combining evidence from these study types. This will be followed by presentations from Dr. Grammati Sarri and Dr. Thomas Debray, who will explain the framework's development, its practical application, and its key recommendations, including:

• Searching for and selecting evidence from NRS and RCTs.
• Analyzing and interpreting this evidence in a way that accounts for trade-offs between availability, quality, and applicability.

The webinar will conclude with an interactive 15-minute discussion, providing attendees the opportunity to engage with the presenters on key topics such as evidence quality, applicability, and the need for future research.

Learning Objectives

• Understand the value of combining evidence from NRS and RCTs in healthcare decision-making.
• Explore the 7-step ISPE framework for reliably synthesizing evidence from these study types.
• Learn how to critically assess, analyze, and interpret evidence from RCTs and NRS while addressing methodological challenges.
• Gain practical insights into building trust in analytical methods and ensuring reliable effect estimates for healthcare decisions.

This webinar is a unique opportunity to explore cutting-edge methodologies in evidence synthesis and advance your understanding of how RWE can complement RCT data in decision-making settings. Join us to learn, discuss, and contribute to shaping the future of healthcare research!