Real-World Evidence

Bringing healthcare decisions closer to real life

Healthcare systems are generating enormous amounts of data every day. Advances in digital health, wearable technologies, and routine care delivery are expanding the availability of real-world data (RWD), which is increasingly being aggregated and applied across regulatory assessments, evidence frameworks, and healthcare decision making.

Real-world evidence (RWE) uses data sources to help stakeholders understand how treatments perform in routine clinical practice, outside the controlled setting of clinical trials. As the use of RWE continues to grow, attention is increasingly focused on enhancing data availability, quality, and transparency to ensure confidence in real-world insights.

Where does RWE come from?

RWE draws on data from sources such as:

• Electronic health records from doctors' offices and hospitals 
• Patient registries that track specific diseases or treatments 
• Insurance claims and billing information 
• Wearables such as smartwatches and fitness trackers

How is real-world evidence being used today?

Real-world evidence is now being applied across a wide range of healthcare decisions, including:

• Regulatory assessment and oversight — Supporting evaluations of safety and effectiveness, particularly when clinical trial data are limited or when ongoing evidence is needed after approval
• Health technology assessment and coverage decisions — Helping payers and assessors evaluate value, uncertainty, and real-world performance of treatments
• Monitoring and evaluation — Informing understanding of long-term outcomes, treatment patterns, and real-world use across healthcare systems

How does transparency build trust?

As RWE use expands, transparent study design, reporting, and data governance are essential. Clear documentation of methods and data sources helps ensure confidence in findings and supports regulatory, payer, and policy decisions.

Who uses real-world evidence?

RWE is used by many professionals:

• Doctors and nurses use it to understand how treatments work for their patients in everyday life, including outside the medical setting.
• Pharmacists use it to see how well medicines work and how safe they are when used by real people. 
• Regulatory agencies (like the US Food and Drug Administration and European Medicines Agency) use it to make sure medicines and treatments are safe and effective after they are approved and being used by the public.
• Payers (such as government bodies and insurance companies) use it to decide which treatments to cover and how much to pay for them, ensuring they support the best care for their members.
• Health policymakers rely on it to create guidelines and policies that help improve healthcare systems and outcomes for everyone.
• Patient advocacy groups use it to support their efforts in improving care and access to treatments for patients.