US FDA Seeking More ‘Open Access’ To Real World Data From Payers
Agency is paying “enormous sums” to access postmarket information from payers, Commissioner Gottlieb says, suggesting public-private partnerships to enhance access.
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Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use.
Effort to replicate clinical trial results with real-world data could eventually allow for increased use in drug development.
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