Real world evidence, or RWE for short, is the term made famous by the 21st Century Cures Act, a law enacted by the United States Congress in December 2016.
Section 3022 of the bill calls for the FDA to establish a program and framework for evaluating the use of RWE, defined as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials.”
In other words, RWE is health care information gathered outside of a typical clinical trial environment. Instead, the data is collected from “atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiveness of drugs and devices.” . To clarify the term, and to provide guidance on the relevance and proper collection of RWE, the FDA has also provided a Use of Real-World Evidence Document.
The push for RWE encourages pharmaceutical companies to collect data about drug usage following FDA approval as well as during actual patient interaction. The benefits of RWE for patients, pharmaceutical companies and the healthcare industry as a whole are significant.