Real-World Evidence (RWE)
Whereas RCTs test what a treatment can do under ideal conditions, RWE reveals what it actually does across diverse patient populations in routine clinical practice. RWE is generated by analyzing sources such as medical claims (Mx), pharmacy claims (Rx), electronic health records (EHR) and patient registries. Regulatory agencies including the FDA increasingly accept RWE to support expanded indications, post-market surveillance and safety monitoring, making it a strategic priority for life sciences teams.
TL;DR
RWE is clinical evidence about how a treatment actually performs, drawn from real world data sources like claims, EHRs, and registries rather than controlled clinical trials.
CATEGORY
Life Sciences
WHO IT IMPACTS
Life sciences researchers, regulatory affairs teams, health economists, payers and clinical operations professionals
RELATED TERMS
DEFINITION
RWE is clinical evidence about the usage, effectiveness and safety of a drug, device or intervention derived from the analysis of real-world data – data generated outside the controlled setting of a randomized clinical trial (RCT).
WHY IT MATTERS
- Shows how a treatment performs across diverse, everyday patient populations, not just under the controlled conditions of a trial
- Increasingly accepted by regulators like the FDA to support expanded indications, post market surveillance, and safety monitoring
- Draws on multiple data sources, including Mx, Rx, EHR, and patient registries, for a fuller picture of treatment impact
- Can complement or accelerate traditional trial pathways, making it a growing strategic priority across life sciences
Example: A pharma company seeking FDA approval for a new indication of an existing oncology therapy might use RWE from claims and EHR data to demonstrate that patients with a specific biomarker profile achieve meaningful clinical benefit, which can complement or accelerate the traditional trial pathway.