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Session 3: Research and Related Initiatives to Evaluate and Improve Real-World Evidence and Real-World Data
Session Chair(s)
John Concato, MD, MPH, MS
Associate Director for Real-World Evidence Analytics, OMP, CDER
FDA, United States
Delphine Saragoussi, MD, MSc
Executive Director, Real-World Evidence
PPD, part of Thermo Fisher Scientific, France
In addition to reviewing regulatory submissions, publishing guidance documents, conducting health technology assessments, and other activities, regulatory agencies and assessment organizations provide support for research and related initiatives that address knowledge gaps in seeking to improve RWD/RWE. This session will present an overview and specific examples of such efforts, some of which are described as “demonstration projects.” Specific topics to be covered include efforts to a) enhance the use and quality of RWD, b) better understand study designs that generate RWE, and c) develop tools for enabling RWD/RWE.
Part 1: Health Technology Assessment (HTA) organization perspective
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize how regulatory agencies and health technology organizations support research and related initiatives
- List the conceptual topics that are commonly addressed by corresponding activities
- Describe how results obtained from these activities promote an improved drug development process
Speaker(s)
Speaker
Tarry Ahuja, DrSc, MSc
CADTH, Canada
Director, Post Market Drug Evaluation (PMDE)
Speaker
Daniel Malone, PhD, RPh
Skaggs College of Pharmacy, Univeristy of Utah, United States
Professor, Department of Pharmacotherapy
Speaker
Curran Sidhu, MS
Evidera, United States
Senior Consultant, Value & Access
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