The evolution of real-world evidence

Once on the sidelines of scientific decision-making, real-world evidence has steadily taken centre stage – reshaping how the value of medicines is measured, demonstrated, and delivered. Powered by digital transformation, policy shifts, and a growing demand for data that reflects real patients in real settings, RWE has evolved from a quiet companion to clinical trials into a leading actor in the story of market access.

Here, we trace RWE's remarkable evolution from its handwritten roots through technological breakthroughs, methodological advancements, and regulatory milestones that have collectively elevated real-world evidence from peripheral consideration to central pillar in pharma market access.