Real-World Data/Real-World Evidence

Real-world data (RWD) refers to data derived from sources outside of traditional clinical trials or controlled research settings, such as electronic health records (EHRs), medical claims, patient surveys, and more. Real-world data is increasingly recognized as a valuable resource for healthcare research, outcomes assessment, and decision-making.

What is real-world data?

Real-world data is data related to patient health status or healthcare delivery derived from real-world settings. It reflects the routine delivery of healthcare and the experiences of patients in everyday clinical practice. Real-world data is valuable for providing insights into the effectiveness, safety, and outcomes of medical interventions in diverse patient populations and actual clinical settings.

What are sources of real-world data?

Real-world data can be sourced from a variety of places, including:

• Electronic health records (EHRs): Digital records of patients’ health information maintained by healthcare providers
• Medical claims and prescription drug claims: Information related to healthcare services, such as procedures, diagnoses, and prescriptions, and associated costs submitted for reimbursement
• Patient registries: Databases that collect and store information about individuals with a particular condition or disease
• Health surveys: Data obtained through surveys and questionnaires that capture patients' perspectives and experiences
• Wearable devices: Data collected through wearables or mobile applications monitoring health parameters

How is real-world data related to clinical trials?

The analysis of real-world data, leading to real-world evidence (RWE), can complement traditional clinical trial data and offer a more comprehensive understanding of how healthcare interventions perform in the real world. Researchers, healthcare providers, and regulatory agencies are exploring ways to leverage real-world data to improve the quality of healthcare and inform evidence-based decision-making.

What is real-world evidence?

Real-world evidence (RWE) refers to the clinical evidence related to the use of and potential benefits or risks of a drug or device that is derived from analyzing real-world data (RWD). In other words, real-world evidence is generated by studying data collected outside the controlled environment of clinical studies, providing insights into how interventions perform in routine clinical practice and diverse patient populations. The goal is to complement and expand upon evidence gathered from traditional clinical trials.

What’s the value of real-world data vs. real-world evidence?

Real-world evidence provides value in several different ways:

• Diverse sources: Real-world evidence is drawn from various sources of real-world data, such as electronic health records (EHRs), medical claims and billing data, patient registries, health surveys, and data from wearable devices or mobile health apps.
• Observational studies: RWE is often generated through observational studies, which analyze data from patients who receive standard care rather than being subjected to controlled experimental conditions.
• Longitudinal analysis: Real-world evidence allows for the analysis of data over extended periods, providing insights into the long-term outcomes and effects of medical interventions in real-world settings.
• Pragmatic considerations: RWE reflects the practical and less-controlled conditions of routine clinical practice, offering insights into the actual use, effectiveness, and safety of healthcare interventions in diverse patient populations.
• Complementary to clinical trials: Real-world evidence is considered complementary to traditional clinical trial evidence, providing a more comprehensive understanding of how medical products perform in broader and more representative patient populations.
• Post-marketing surveillance: RWE is crucial for post-marketing surveillance of drugs, biologics, and medical devices. It helps monitor the safety and effectiveness of these products after they have been approved and are in widespread use.

Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), increasingly recognize the importance of real-world evidence in informing healthcare decision-making, regulatory decisions, and post-market surveillance. The integration of real-world evidence contributes to a more comprehensive and pragmatic understanding of the performance of medical interventions, including drugs and devices, in real-world clinical settings.