IIn a previous post, I discussed the FDAs publication of a framework for Real World Evidence (RWE) last December, and we’ve looked at its use in drug and device submissions since then. The agency, in cooperation with the Duke Margolis Center for Public Health Policy, is hosting a workshop on RWE on October 3rd in Washington, DC. Readers will recall the Margolis center operates the RWE Collaborative to guide the development and use of RWE in collaboration with multiple stakeholders. These key questions presented in the framework will be discussed:
- Is the RWE fit for use?
- Does the trial or study design used to generate RWE provide adequate scientific evidence to answer or help answer the regulatory question of interest?
- Did the conduct of the study meet FDA regulatory requirements?
Other and emerging topics in RWE will be discussed. White papers from the Collaborative will also be released and discussed as part of workshop sessions. You may register for the workshop here. I also anticipate the proceedings will be made available on the web at a future date.
Reach out to me if you want to know more or discuss your medical product development needs.
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Text Copyright © 2019 Katrina Rogers