DIA 2022 Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-569-L04-P ; CME 1.00; RN 1.00

Real-world evidence (RWE) is increasingly used to complement randomized clinical trials (RCT), provide a better understanding of real-world effectiveness, and address information gaps. This session will explore various best practices, tools, and methods used.

Learning Objectives

Describe various levels of real-world evidence (RWE) validity and their relationship to current regulatory RWE guidance; Identify rigorous methodological approaches to maintain evidentiary standards and the impact of underlying data quality in RWE study results; Evaluate future study design using advanced RWE to support medical affairs, market access, and regulatory objectives.

Chair

Dan Riskin, MD, MBA

Speaker

Developing High-Validity Real-World Evidence to Meet Clinical, Regulatory, and Commercial Objectives
Dan Riskin, MD, MBA

FDA Update
John Concato, MD, MPH, MS

Practical Tools to Advance Fit-for-Purpose Use of Real-World Data in Regulatory Decision-Making
Cathy W Critchlow, PhD, MSc

Evaluating Machine Learning Derived Real-World Data to Support Regulatory Decision Making
Irene Nunes, PhD