Real World Evidence is Changing Regulatory Policy

Hardly a day goes by without the pharmaceutical industry, patients, and the various national and supranational pharmaceutical regulatory agencies in Europe discussing how they can leverage the power of real world evidence (RWE) in order to improve access to valuable treatments and medical technologies. This was illustrated by a recent success story on the use of RWE in a U.S. retrospective study of more than 3.8 million electronic medical records of people who received a seasonal influenza vaccine. This revealed that the MF49-adjuvanted seasonal influenza vaccine was more efficacious than other similar vaccines in real-world settings.