<unk>  (RWE) in medicine means<unk>  obtained from real<unk>  data (RWD), which are observational data obtained outside the context of randomized controlled trials (RCTs) and generated during routine clinical practice. RWE is generated by analyzing data obtaned from hybrid trials, pragmatic trials, and late phase trials. Such data is stored in electronic health records (EHR), medical claims or billing activities databases, registries, patient-generated data, mobile devices, etc. It may be derived from retrospective or prospective observational studies and observational registries. In the USA the 21st Century Cures Act required the FDA to expand the role of<unk> .<unk>  comes into play when clinical trials cannot really account for the entire patient population of a particular disease. Patients suffering from comorbidities or belonging to a distant geographic region or age limit who did not participate in any clinical trial may not respond to the treatment in question as expected. RWE provides answers to these problems and also to analyze effects of drugs over a longer period of time. Pharmaceutical companies and Health Insurance Payers study RWE to understand patient pathways to deliver appropriate care for appropriate individuals and to minimize their own financial risk by investing on drugs that work for patients.
Real world evidence
Real world data
Safety pharmacology
Predictive medicine
Universal design
Comparative medicine
Scientific consensus
Glossary of clinical research