Real World Evidence: Between 'Nirvana' And Electronic Roadblocks
US FDA's Jonathan Jarow says it will be up to pharma industry to get right data into electronic health records.
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Independence, But Not Isolation: Panel Of FDA Commissioners Reflect On Role Of Dialogue With External Stakeholders
US FDA Commissioner Scott Gottlieb and three former agency heads tout value of deliberation with broader scientific community, but also agency's ability to make regulatory decisions independently.
In a journal article, Center for Drug Evaluation and Research Director Janet Woodcock and colleagues describe the sources of real-word evidence and study designs that can be used to generate such evidence.
Postmarketing studies randomized to look at real world data sets could provide the key, Temple suggests; Amgen rep describes use of real world data to support approval of leukemia drug Blincyto.