Fact Sheet

Real-World Evidence

PhRMA September 6, 2016

Rapid advances in technology and science have enhanced our ability to use unprecedented volumes of data to generate important insights on the use, benefits and risks of medicines. Some of these data are gathered from the real-world practice of medicine and are called real-world evidence (RWE).

RWE is gathered after a medicine or treatment has been approved by the U.S. Food and Drug Administration (FDA) and is being prescribed by physicians to real-world patients. RWE can come from a variety of sources, including electronic health records, payer administrative claims and patient registries. RWE may lead to more efficient drug development programs and could ultimately lead to more timely access to innovative, safe and effective medicines for patients.