Comparing and Contrasting RWE Guidance: What Researchers Need to Know Considering the Global Picture

Speaker(s)

Moderator: Ulka Campbell, PhD, MPH, Aetion, Inc, New York, NY, USA
Panelists: Patrice Verpillat, MD, MPH, PhD, European Medicines Agency (EMA), Amsterdam, Netherlands; Pall Jonsson, BSc, PhD, National Institute for Health and Care Excellence (NICE), Manchester, LAN, UK; Solange Corriol-Rohou, MD, PhD, Global Policy, Pharmaceutical Company: AstraZeneca, GMD, Paris, 75, France

Presentation Documents

ISSUE:

In the last five years, there has been a proliferation of RWE guidance issued by regulators and HTA agencies covering use cases, and design, data, and submission considerations for decision-grade RWE. For researchers, it may be challenging to track and operationalize guidance, particularly when designing a comprehensive evidence strategy for multiple stakeholders. As examples, different terms are used for similar concepts (e.g., data quality), and the same concept is described with variable emphasis. Stakeholders have called for more harmonized and efficient provision of guidance. To address this need, this panel will compare and contrast available guidance and propose areas for harmonization.

OVERVIEW:

The moderator (Ulka Campbell) will present a review of recent guidance on real-world data (RWD) quality from the FDA, EMA, NICE, HAS, and IQWiG. RWD quality will be used as an example to focus the conversation, but the panel will cover other topics covered in guidance. The panel will discuss the similarities and differences among the guidances. Solange Corriol Rohou will discuss how they interpret and operationalize these guidances for different decision-makers. Páll Jónsson and Patrice Verpillat will provide their perspectives on how researchers should consider similarities and differences in guidance when designing real-world studies. The moderator will then facilitate a debate on areas for harmonization and more operationalized recommendations.

Code

203

Topic

Organizational Practices