“We live in real world. Come back to it.“
Natalie Portman
What is RWE exactly?
- According to the FDA, RWE is “the clinical evidence regarding the usage and potential benefits or risks of a medical product, derived from analysis of real-world data¨.
- Real-World Data and Real-World Evidence 101. This webinar introduces essential terminology related to real-world data and RWE.
Conceptual and pragmatic considerations around RWE
- Real-World Evidence – Where are we now? Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions. A Perspective in the NEJM by Concato and Corrigan-Curay
- COVID-19 Opens a New Era for Real-World Evidence in Pharma. The desire to drastically accelerate research and development, reinforced by a greater understanding of data science, has made the health care community more receptive to expanding the use of RWE beyond traditional safety-related applications. An article by Wierbza et al, from the Boston Consulting Group.
- Evidence for Health Decision Making — Beyond Randomized, Controlled Trials. In this article in the NEJM, Thomas Frieden calls for greater use of alternative data sources, other than randomized controlled trials, for health care decision making.
- Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth. In this article, Eichler et al. explain why generating knowledge about safety and effectiveness of drugs should rely both on randomized controlled trials and RWE.
- Creating value from next-generation real-world evidence. Insights on RWE by Champagne et et al, from McKinsey & Company. Leading pharma companies are applying advanced analytics to real-world evidence generation to deliver impact at scale. How can leaders keep innovating, and what should others do to catch up?
- The use of Real World Evidence – Opportunities for Europe. A series of 5 articles by the London School of Economics to capture insight on the use of RWE in a number of European countries from key experts, including representatives from academia, health services, government bodies, payers and patient associations.
- A Framework to Guide the Optimal Development and Use of Real World Evidence for Coverage and Formulary Decisions. A series of two articles, by Institute for Clinical and Economic Review (ICER) and the Office of Health Economics. The papers set out the potential opportunities and important challenges and limitations that must be addressed in considering options for using RWE to inform insurer coverage decisions.