October 26, 2021
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:
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.
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:
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.
October 26, 2021
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:
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.
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:
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.