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Real-World Evidence: US FDA Framework Emphasizes Data Fitness And Study Quality

 
• By Sue Sutter

Agency’s approach to assessing real-world evidence for effectiveness will be guided by three key principles: fitness for use of the underlying data, adequacy of the study design, and satisfactory monitoring and data collection.

Man on treadmill

The US FDA’s approach to real-world evidence (RWE) generally, and specifically for supplemental applications seeking new effectiveness labeling claims, will be guided by three key principles: data fitness, study design fitness, and study conduct.

The agency’s RWE framework describes a conceptual approach to evaluating the potential use of evidence generated outside the traditional clinical trial setting to support regulatory decisions about product effectiveness.

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