Authors: Lea Ann Browning-McNee, MS1; Mary McNamara1
1Reagan-Udall Foundation for the FDA
The coronavirus pandemic brought an unprecedented need to rapidly produce safe and effective diagnostics, therapies, and vaccines. The demand to accelerate research and development, reinforced by a growing availability of real-world data (RWD), have made the health care community and the larger public more aware and receptive to the use of real-world evidence (RWE). However, there is also skepticism about using RWE to support clinical or regulatory decision-making. In August of 2021, World Health Organization officials reported that misinformation about COVID-19 and vaccines was a factor in vaccine hesitancy and in an increase in cases around the world.1