US FDA Officials Provide Primer On 'Real-World' Data
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.
You may also be interested in...
US FDA's Woodcock tells the Pink Sheet that goals include eliminating duplication through creation of one safety review process.
With Flatiron, Roche is at the forefront of the emerging field of RWE. Roche Pharma President O’Day described how the company is using such data in the real world of regulation and reimbursement.
Effort to replicate clinical trial results with real-world data could eventually allow for increased use in drug development.