When real-world evidence is sought, medical device registries can prove to be valuable fields for data mining. However, most medical devices never get listed in registries. Does this mean that manufacturers and researchers won’t be able to find adequate real-world data? “Just because the data is there doesn’t mean that it’s appropriate for real-world evidence generation,” said Heather Colvin, director of evidence and outcomes policy for MD regulatory affairs at Johnson & Johnson. Colvin went on to say, “You need to manage expectations so that your team does not expect RWE for every product. If a product is newly on the market or used in a small population, there just has not been enough time for sufficient accrual of real-world data.”
Global efforts to harness RWE from diverse sources other than registries are increasing, as are attempts at harmonization and coordination. But this also means that policy challenges centered around data quality and methodology are also emerging. “Governance issues around access, data sharing and transparency are being worked through as well. Those seeking to use RWE also must address patient informed consent, cybersecurity issues, and other ethical concerns,” said Colvin. Read more here.
(Source: Kari Oakes, Regulatory Focus September 17, 2020)