See All Resources by Project
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:
- Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19 (Publication)
- 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)
Proceedings, Publications, & Public Comments...
- 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)