Imagine: Your pharmaceutical or medical device has been tested in carefully designed
clinical trials and shown to meet required standards of efficacy and safety. It has gained
regulatory approval and has gone to market. Now you want to know, does it measure
up to its promise when used in the real world? Does it materially improve patient
outcomes? Does it outperform alternative therapies? Does it achieve these outcomes at
an appropriate value? Do you know which patients are most likely to benefit from it?
Can you prove it, with statistical rigor?
As the health care system moves toward a patient-centric, value-based approach,
questions such as these are getting heightened scrutiny from all angles – from regula-
tors, payers, providers and patients. And they should. Real-world evidence (RWE) can
provide new insight into the benefits, risks and cost effectiveness of medicines and
medical devices in actual use – evidence that can enable life sciences companies to
develop better therapies