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Real-World Evidence: Advice, Principles And Examples Emerge From FDA

 
• By Cole Werble

Biopharma sponsors are eagerly awaiting guidance on how to apply 'real-world evidence' to drug development and regulatory decisions. Recent workshops provide some clues about what is likely to be included in the first drafts.

Yellow road sign with a blue sky and white clouds: clinical trial

US FDA officials appear most comfortable applying “real-world evidence” to the challenges of patient selection for clinical trials – rather than jumping ahead to using those data sources as a basis for a drug approval decision.

During a week of workshops focused on the theme of real-world evidence in mid-September, FDA officials repeatedly made the point that the agency can, does and will use real-world evidence...

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