ARTICLE SUMMARY:
In part 2 of a 2-part discussion, Paul Coplan explains how the FDA has supported the use of real-world evidence through its recent guidance and notes how medtech can learn from pharma’s use of this approach, while also illustrating how RWE can be used to advance emerging areas like health equity and AI.
The use of real-world evidence (RWE) is expanding dramatically throughout medtech, both in the US and globally as regulators increasingly recognize the benefits of this approach in terms of increasing efficiency and productivity, particularly in the clinical trials process. Johnson & Johnson is among the product companies leading the way in this effort. In the first part of this interview, Paul Coplan, ScD, VP of the company’s MedTech Epidemiology & Real-World Data Science team, discussed how the medtech leader is breaking new ground by implementing this approach. (See “Pioneering the Use of Real-World Evidence: An Interview With J&J’s Paul Coplan,” Market Pathways, August 13, 2024.) Among its successes was being the first medtech company to receive FDA approval of a label extension using real-world evidence. He also spoke about how RWE is being adopted globally for medical devices, highlighting specific success J&J has had in China, while also noting its use in Europe to help address the added clinical requirements imposed by the recent Medical Device Regulation and In Vitro Device Regulation (MDR and IVDR).
Critical to the increased adoption of real-world evidence has been the cooperation that is occurring between industry and regulators. Coplan explains throughout the interview that a big part of this cooperation is being facilitated by a group that may be unfamiliar to those outside the clinical trials arena: the National Evaluation System for health Technology (NEST). NEST is a creation of the Medical Device Innovation Consortium (MDIC), the public-private partnership between regulators, including FDA and CMS, and industry to help promote and improve medtech regulatory science. (See “Keeping Medtech Real-World Evidence Real,” Market Pathways, August 3, 2020.) J&J and other companies are working closely with NEST on a series of 20-plus test cases designed to serve as initial examples of regulatory success stories using real-world evidence, of which J&J’s label expansion effort was the first.
In the following interview, Coplan addresses the FDA’s recent medtech guidance on real-world evidence, and, sharing his previous pharma experience, points out how the device industry can benefit from the previous experience that drug companies have had using this approach. We conclude the discussion by looking at future applications of RWE, particularly its use in important emerging areas such as health equity and AI. (This interview has been edited for length and clarity.)
