FDA urges validation of digital health endpoints and clear missing-data plans
read at raps ↗RegulatoryNeutral
FDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies.
They said endpoints must be validated for the specific patient population they target.
Sponsors also need to pre-specify how they will handle missing-data at every trial level and keep device clearance separate from endpoint validation.
source
This writeup was produced by pharmadog from original reporting by raps.
Original headline: “FDA officials review best practices for validating digitally derived endpoints”
read at raps ↗80 words · retrieved 9m ago
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