Are There Clear Criteria for Whether Real-World Data Sources Are Regulatory-Grade?
Author(s)
Moderator: Marc L. Berger, MD, Marc L. Berger, LLC, New York, NY, USA
Panelists: Jacqueline Corrigan-Curay, J.D., M.D, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington DC, DC, USA; Jesper Kjær, MSc, Joint Big Data Taskforce, HMA-EMA, København S, Denmark; William Crown, PhD, The Heller School for Social Policy and Management, Brandeis University, Waltham, MA, USA
ISSUE:
Are there clear criteria for whether real-world data sources are regulatory-grade?OVERVIEW:
Marc Berger will open the session. (5 minutes) Jacqueline-Corrigan Curay will discuss how the FDA views RWD quality as it considers using RWE in its decision making with reference to the several relevant FDA guidance documents. (12.5 minutes) Jesper Kjaer will discuss the EMA approach to the issue with reference to the Eu Data Quality Framework and Good Practice Guide for the use of Metadata in the Catalogue of Real-World Data Sources. (12.5 minutes) William Crown will review efforts to harmonize RWD quality criteria as well as provide his thoughts about standards to assess whether a particular RWD source may be fit-for-purpose. (10 minutes) Panel Discussion (20 minutes)Conference/Value in Health Info
2023-05, ISPOR 2023, Boston, MA, USA
Code
309
Topic
Health Policy & Regulatory