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Trials are inspected to check the data are real and traceable. Do the same for the hospital databases used to make regulatory decisions.
Clinical trial data are governed by Good Clinical Practice and inspected; real-world data sources used in regulatory submissions are not. The proposal is a 'GCP for real-world data': standards for provenance, traceability to source records, curation documentation, fitness-for-purpose assessment and inspection rights, with accreditation of data sources. The FDA's RWE framework and EMA's DARWIN EU data quality framework are starting points.
Shares Real-world evidence, Weak real-world evidence and registries, Regulatory divergence between regions.
Shares Real-world evidence, Weak real-world evidence and registries, Regulatory divergence between regions.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries, Regulatory divergence between regions.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries.