Defining Fit For Purpose Real-World Evidence for Supporting Companion Diagnostics Approvals: Creating a Checklist for Evaluating Real-World Data
Time: 12:00 pm
day: Foundation Medicine Workshop
Details:
- Trends in the use of RWD/E for regulatory approvals in oncology and potential CDx use cases
- Foundation Medicine’s Fit-For-Purpose RWE Framework for CDx and RWD/E for CDx Checklist for evaluating RWD/E
- Case Study: Approval of FoundationOne®CDx to be used as a companion diagnostic inclusive of post-approval study leveraging the Flatiron Health – Foundation Medicine Clinico-Genomic Database (CGDB)
