Leveraging Real World Data to Better Inform Clinical Trial Design and Implementation

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• Factors leading to the increased need and utilization of RWD
• The 21st Cure Act of Congress and FDA’s mandate to develop RWE program for drug development
• Types and roles of RWD in the drug development life cycle: past and present
• How we are currently able to leverage RWE to inform clinical trials by phase
• Example for leveraging RWE to inform and support clinical trials
• Current limitations of RWD and RWE