Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.
Art SedrakyanDanica Marinac-DabicBruce CampbellSuvekshya AryalCourtney E BairdPhilip P GoodneyJack L CronenwettAdam W BeckElizabeth W PaxtonJim C HuRalph BrindisKevin BaskinTerrie CowleyJeffery LevyDavid S LiebeskindBenjamin K PouloseCharles R RardinFrederic S ResnicJames TchengBenjamin FisherCharles VivianoVincent DevlinMurray SheldonJens Eldrup-JorgensenJesse A BerlinJoseph P DrozdaMichael E MathenySanket S DhruvaTimothy FeeneyKristi MitchellGregory PappasPublished in: BMJ surgery, interventions, & health technologies (2022)
We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.
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