Pharmaceutical and device companies increasingly must demonstrate evidence on real world outcomes in order to differentiate their products in a saturated and competitive environment and prove value to a price-sensitive healthcare marketplace, which includes regulators, insurance companies, healthcare providers and individuals to whom the products will be prescribed. Proving safety and efficacy before product launch alone is not enough to remain profitable while satisfying the additional scrutiny and demands of healthcare stakeholders.
Real world evidence (RWE) involves patient healthcare data, intentionally collected outside of the randomized controlled clinical trial (RCT) environment to provide information on relevant health outcomes, including cost of care. This evidence provides insights into unmet needs, interventional pathways and the clinical and economic impact on patients and the healthcare systems involved.
RWE-based approaches and data sources each have unique benefits and special considerations that must be properly addressed in order to generate trusted, valid and useful data.