Real-world evidence (RWE) derives from data collected outside of highly-controlled randomized clinical trials (patient reported outcomes, registries, databases, surveys, etc). RWE is rapidly gaining importance in healthcare decision making, as reflected in the various guidances that have already been issued or are planned by the EMA and FDA. In this review, we introduce the concept of RWE, describe the main RWE study designs, comment on the most relevant criteria that have to be taken into account, and include the TFS-RWE algorithm to find the most suitable design for you. Finally, we provide an overview of the European Union and United States regulations on RWE.
RWE Study Design
