Real-World Evidence (RWE) is has been driving decisions in healthcare since its framework was developed in Congress in 2016. RWE is defined by the FDA as the bottom line drawn from data collected from EHRs, billing and claims activities, product and disease registries, patient-generated data, and data gathered from other sources such as mobile devices.

The FDA uses RWE to monitor safety after clinical trials are concluded and a therapy is put into practice. When asked what this means for patient care, Samuel Bozzette, VP Chief Scientist for Premier Applied Sciences, said that understanding the evidence on how therapies impact outcomes when used “on the front lines” will help control costs and improve quality. Clinical trials are specifically confined by eligibility requirements that their results often are not reflective of outcomes in practice. Bozzette states that RWE presents a, “paradigm shift” in how research is conducted.”

Drawing conclusions from heterogeneous populations in diverse clinical practice settings can help create best practices for existing and new treatments. When asked why providers should care about RWE, Bozzette pointed out that this type of research is focused on both short and long-term outcomes, with implications for efficiency and cost control, both significant measures as the healthcare community looks towards value-based care.

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