Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

External or historical control arms are at the forefront of real-world use of real-world evidence (RWE) in regulatory decisions about efficacy. And Roche, having acquired Flatiron Health Inc. and its database of electronic health records, is at the head of the pack.

The company has already used external control arms generated from electronic health records (EHR) data in reimbursement negotiations for Alecensa and Tecentriq, and Roche Pharmaceuticals CEO DanielO’Day expressed optimism about...