Real World Data Drives Real World Evidence

Real-World Data (RWD) is playing a bigger role than ever with regulatory bodies looking for Real-World Evidence (RWE) to support pre- and post-market decisions. In March 2016, the US Food and Drug Administration (FDA) released the Prescription Drug User Fee Act, which includes the use of RWD and RWE in regulatory decision-making. Aiming to expedite approval for new medicines, the 21st Century Cures Act became law six months later and includes provision for RWE to be used in place of evidence from randomized controlled trials (RCTs). An increasing number of FDA submissions are including RWD and RWE for approval.

Partnering with MSA experts helps the Life Sciences industry overcome two main challenges regarding RWD:
(1) Protecting patient privacy within the HIPAA patient privacy and protected health information (PHI) laws
(2) Collecting and connecting data throughout the entire patient experience, not just pieces.

The Pharma and Life Sciences industries can use the RWD provided by MSA to generate Real-World Evidence to gain powerful insights into how treatments perform among specific patient based on comorbidities, age, socio-demographics, etc. – subgroups that may have not been studied in the randomized controlled trials (RCTs). The MSA provided longitudinally-aligned, anonymous patient-level datasets enable insights to a patient across their journey or over a lifetime.

MSA Healthcare Data Management’s ability to attain and link RWD from across the entire patient journey is fueling the research and analyses necessary to draw RWE conclusions that answer real-world questions and predict outcomes.

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