Bridging the Gap between Clinical Development and Patient Access with Real-World Evidence

EPM Magazine
May 2018
Author: Dr. Chitra Lele, Sciformix Corporation

Real World Evidence (RWE) is defined by the FDA as ‘clinical evidence regarding the usage and potential benefits or risks of medical products derived from analysis of Real World Data (RWD)’.1RWD is the data collected from sources other than traditional clinical trials. These data are being obtained from electronic tracking systems used to capture patient experiences during care.

RWE is increasingly crucial for life science companies to ensure patient access and commercial success. Generating and leveraging RWE requires technical expertise along with strategic insights for informed healthcare decisions and optimal outcomes. However, as the sources of RWD are disparate and the quality can vary greatly, accessing, analysing and drawing conclusions from the data is more challenging than ever. Going forward, Real World Evidence will become increasingly more patient centric, as highlighted through the growing emphasis by payers and regulators for advances in this area.

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