Sponsors Find Benefits, Barriers in Using Real-World Evidence

As the FDA expands its use of real-world evidence, medical device companies are starting to see the benefits — and the challenges.

Early adopters of real-world evidence have had success with label-expansion in particular, and companies and sponsors have also successfully used RWE to fulfill post-marketing commitments, said Mary Jo Lamberti, professor and associate director of sponsored research at the Tufts Center for the Study of Drug Development, in an FDAnews webinar.

Lamberti outlined results of the center’s recent study on the use of real-world evidence and data, which found that difficulty getting robust, standardized data was the top challenge cited by regulators, electronic health record vendors, payers, health systems and patient advocacy groups.