Real-World Evidence (RWE)
According to the definition of the HTA Glossary, real-world data (RWD) is the “data collected during the routine delivery of health care” (1). Real-world evidence (RWE) is “derived from the analysis of RWD” and “characterized by the actual use of the technology in practice and by findings that are generalizable to the target population for the technology” (2). Regulatory and HTA decision-makers increasingly use RWE to enrich the evidence in the decision-making processes. It can be about disease history, epidemiology, patient health status, health outcomes, economic evaluation of using a health technology/intervention, etc. The sources of RWD may include patient-generated data, professional-generated data, administrative data, observational data, and research data (1). These data are usually collected with the:
- Electronic medical records (EMR) and electronic health records (EHR)
- Administrative health datasets
- Claims and billing datasets
- Disease and product registries
- Case notes
- Observational studies
- Mobile health applications
- wearables
- environmental sensors
- smartwatches
- tablets
- cellphones
- Health surveys
- Interviews and focus group discussions (FGD)
- Social media
The relevance and reliability of RWE, on top of the methodologies used to generate the RWE, play a significant role in technology appraisal and decision-making.
Quality HTA optimizes the quality and potential of data and helps you from data collection, evaluating the reliability of data sources and the methodologies to the assessment of the evidence to incorporate into the regulatory and reimbursement processes.
