“FDA recommends sharing your protocol and statistical analysis plan before the real-world study is conducted… to ensure the analysis wasn’t cherry-picked.”
MD
Meryl Dersarkissian
FDA Watch ·
“You need to do what we call a structured feasibility assessment. So you need to know if the real world data source is fit for purpose for the specific research question.”
Marianne Cunnington · FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 4: RWE in Postmarketing Studies
Play from 15:37
15:37
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What was described
perform a structured feasibility assessment to determine if a real-world data source is fit-for-purpose for a specific research question before starting a post-marketing study
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