What is real-world data (RWD)?
Real-world data (RWD) includes health information collected from sources such as electronic health records (EHRs), insurance claims, patient registries, mobile health apps, and observational studies. Unlike data from randomized controlled trials (RCTs), RWD reflects how treatments are used in everyday clinical settings, capturing patient diversity, long-term outcomes, and treatment patterns across broader populations.
Why is real-world data important in pharmaceutical development and decision-making?
RWD provides insights into the effectiveness, safety, and value of treatments under real-world conditions. It supports regulatory submissions, label expansions, health economic modeling, and payer negotiations. RWD is also essential for understanding patient journeys, identifying unmet needs, and evaluating outcomes in subpopulations not well represented in clinical trials. As healthcare systems move toward value-based care, the role of RWD in demonstrating real-world impact and informing evidence-based decisions continues to grow.
