According to the FDA, real-world data (RWD) are data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources, including:

• Electronic health records (EHRs)
• Claims and billing activities
• Product and disease registries
• Patient-generated data including in home-use settings
• Data gathered from other sources that can inform health status, such as mobile devices

Alone, RWD have limited applications, but when properly organized, integrated, and correlated against longitudinal outcomes, may become real-world evidence (RWE).  The FDA defines RWE as “evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data.”

RWE generation, therefore, requires a methodical application of robust analytics against proper sources of RWD deriving from routine clinical care.
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Why is Real-World Evidence Valuable?

In healthcare, there’s a gap between traditional clinical research, such as double-blinded, placebo trials, and everyday clinical procedures, interventions, and office visits. This gap creates a growing discrepancy between studied outcomes against curated patient populations, and actual outcomes across a heterogenous population.

RWE addresses those gaps by correlating RWD stemming from a larger, more genetically diverse, and therefore more broad-patient relevant population. As just one example, a medical manufacturer could more cost-effectively generate RWE to satisfy the following post-market obligations:

• Detecting adverse events for a new device.
• Comparing new products or treatments with existing options and the standard of care for different patient cohorts.
• Updating clinical guidelines.
• Complying with regulatory requirements.

RWE has the potential to drive cost-efficiencies, address evidence-based gaps throughout the healthcare system, and ultimately drive more predictable, personalized patient outcomes.

If you’re interested in learning more about how real-world data and real-world evidence could support your healthcare goals, talk to one of our experts.
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