Highlighting the history of RWE (Sentinel Program (what it is and its impact); Natural History Studies; 21st Century Cures Act; Overview of Post-Cures Act FDA Regulatory Guidances; RWE Regulatory Approvals; and RWE and Covid-19. The practical use of RWE 1) FDA Criteria for accepting RWE, 2) Types of data (including PGHD and registries, 3) Study designs and, 4) Totality of Evidence approach.
The transition to an International Use of RWE including new EMEA draft guidance on using registries and Challenges in RWE (Transparency, Access to Data, Challenges of interoperability, and data unavailability in consistent formats, Privacy and Determination of when RWE is acceptable).
Closing with the future of RWE and potential applications of RWE.
Celestin A, Hyatt Regency New Orleans
Ann Hartry, Cerise James, Esther Liu