FAQ on rwe

Real-world evidence (RWE) is derived from the analysis of real-world data (RWD). RWD are data relating to patient health status and/or the delivery of healthcare that can be generated from various sources –for example from patient registries or patient-reported outcomes (PROs).

Real-world evidence (RWE) studies can generate data from many sources. They could be prospective observational studies designed to collect data from patients in the real world, or retrospective studies using existing patient registries.

Health economics and outcomes research (HEOR) can be used by biopharma companies to collect real-world evidence (RWE) and support the drug development process. In this context, HEOR involves using rich datasets to explore how drugs are being used to treat patients and how they are performing clinically.

“HEOR” stands for health economics and outcomes research. Health economics focuses on measuring and valuing healthcare interventions, while outcomes research involves evaluating the effect of healthcare interventions on patients. HEOR is the combination of these two fields to provide valuable data for healthcare decision-makers.

Market access within healthcare means ensuring that a medicine is fairly priced and reimbursed, and that it is accessible to those who need it. To gain market access for their products, biopharma companies must demonstrate clinical and economic evidence to providers, healthcare decision-makers, and payers.

Patient-centered outcomes (PCO) research is the evolution of traditional clinical research to focus on the preferences, beliefs, and needs of patients. The active and meaningful engagement of patients in research and patient-centered evidence is increasingly being valued among regulators and payers.