What is Real World Evidence?

Real World Evidence (RWE) is a term increasingly being used within the healthcare and pharmaceutical industries, shaping critical decisions around drug approvals, patient treatments, and healthcare policies. But what exactly is Real World Evidence, and why has it become so important?

Real World Evidence refers to clinical data collected outside the tightly controlled environment of randomised controlled trials (RCTs). While traditional clinical trials focus on assessing treatments under strict conditions, RWE is drawn from real-world settings such as patient registries, electronic health records, claims databases, wearable devices, and observational studies.

Real World Evidence is generated from diverse sources, including:

• Electronic Health Records (EHRs): Digital patient records containing comprehensive clinical data.
• Patient Registries: Organised systems that collect uniform data to evaluate outcomes for populations defined by a specific disease, condition, or exposure. 
• Claims and Billing Data: Records from insurance providers detailing healthcare services utilised, diagnosis codes, and prescribed treatments. 
• Wearable and Mobile Devices: Continuous monitoring devices, such as fitness trackers and digital sensors, providing real-time health data. 
• Observational Studies and Surveys: Research studies designed to observe and collect health outcomes without direct intervention by researchers.

Real World Evidence has become invaluable to healthcare stakeholders including regulators, healthcare providers, pharmaceutical companies, payers, and patients - offering numerous benefits:

While Real World Evidence holds tremendous potential, it is essential to acknowledge challenges and limitations inherent to RWE collection and interpretation:

The role of Real World Evidence is rapidly expanding, especially with advancements in technology and data analytics. Experts predict significant growth in the utilisation of RWE in areas like oncology, rare diseases, chronic illnesses, and personalised therapies.

Real World Evidence is a transformative force in modern clinical research. It bridges the gap between controlled trial settings and real-world clinical practice, offering essential insights that improve patient outcomes, inform regulatory decisions, and advance healthcare delivery.