Evidence generated from observational studies using real world data (RWD), outside of clinical trials, known as real world evidence (RWE), is increasingly being used to inform decision-making regarding the use of medicines.

The use of RWE has gone beyond its usual domains of pharmacovigilance, pharmacoeconomic and outcomes research. RW studies are now conducted during the whole lifecycle of medicines, to enhance drug discovery and development, as well as their contribution to studying post-authorisation safety and effectiveness. The potential for the use of RWE throughout the entire lifecycle of medicines will continue to grow.

Everyone working in biomedical sciences needs to understand the principles, methods and applications of observational RW studies.