In the end of 2018 the FDA established a framework for the new Real World Evidence (RWE) programs.

The FDA (Food and Drug Administration) proposes the use of RWE to generate data that can support or assist the approval of new indications or to support post-marketing studies that may be required. Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in decision making in healthcare and clinical research.

It is important to understand that RWD is patient data collected from a variety of sources, such as electronic medical records; physical, billing data; product and disease registration data; data generated by patients using apps and mobile devices. RWE is clinical evidence obtained from RWD analysis that provides information on the use, risks and benefits of a medical device derived from sources other than traditional randomized clinical trials.

The advancement of this theme is gaining ground in Brazil with the expansion of the use of electronic medical records and the multiplication of digital technologies (Machine Learning), database (Big Data) and artificial intelligence, which provide new sources of data, as well as methods enhanced for capturing, storing and analyzing patient data. Without a doubt, the RWE complement the knowledge obtained through randomized clinical trials, filling gaps that clinical studies are not able to fill.