Why Prospective Real-World Studies Hold So Much Promise For Clinical Research

By Josh Buddle

Clinical research has traditionally been a meticulous and lengthy process, given the high stakes where errors are not an option. However, the slow pace, complexity, and operational challenges have long frustrated stakeholders—including sites, sponsors, healthcare providers, policymakers, and ultimately, patients.

Around ten years ago, real-world evidence (RWE) emerged as a promising new approach, leveraging real-world data (RWD) collected at the point of care. This shift was driven by the widespread adoption of electronic health records, rapid advancements in data technology and infrastructure, and the FDA's 21st Century Cures Act. RWE has since revitalized clinical research.

So, where do we stand now? Biopharma companies are increasingly using RWE across the value chain, from assessing unmet needs to shaping study designs and monitoring outcomes. Yet, RWE is still rarely central in regulatory submissions. Currently, only 1% of Phase IV trials incorporate RWD, and just over 3% of all RWE studies focus on drug-specific effectiveness, discontinuation rates, or adverse events.

However, a new wave of RWE studies—prospective real-world studies—is beginning to change this landscape.