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Real World Evidence

Focus Area: Current Project

Focus Area: Global Regulatory Engagement

Items listed by newest to oldest in each category.

Proceedings, Publications, & Public Comments:

• Can Observational Analyses of Routinely Collected Data Emulate Randomized Trials? (Publication)
• Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness (Publication)
• Understanding the Need for Non-Interventional Studies Using Secondary Data to Generate Real-World Evidence for Regulatory Decision Making, and Demonstrating Their Credibility (Publication)
• Issues in the registration of database studies (Publication)
• Determining Real-World Data’s Fitness for Use and The Role of Reliability (Publication)

Presentations:

• Evaluating RWE from Observational Studies in Regulatory Decision-Making: Lessons Learned from Trial Replication Analyses (Presentation)
• Role of Real World Evidence and ICH-E17: A provocative perspective
• Observational Patient Evidence for Regulatory Approval and uNderstanding Disease (OPERAND) (Presentation)