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Real-World Evidence: Sponsors Will Need Prospective Process Early In Development

 
• By Derrick Gingery

US FDA's approach to clinical trial replication project may offer tips for sponsors looking to use real-world evidence to support drug development.

Clock numbers in close up
The FDA's trial replication project may help sponsors understand how they can incorporate real-world evidence, potentially to streamline development. • Source: Shutterstock

Real-world evidence research conducted by the US Food and Drug Administration may serve as a model for its future use in regulatory decision-making.

David Martin, associate director for real world evidence analytics in the Center for Drug Evaluation and Research, said the agency's approach to its clinical trial replication project is not a policy

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