December of 2018 saw the FDA release their “Framework For Evaluating the Potential Use of Real-World Evidence (RWE)” to support the approval of a new indication for a drug already approved under section 505(c) of the FD&C Act. This document was developed to outline guidance and support of real world data collection efforts for post-approval studies. The document outlines the numerous definitions applied by the FDA to real world data (RWD) and real world evidence (RWE). The framework effectively outlines how each of the safety and effectiveness measures can be applied when conducting studies using real world data and provides the regulatory body’s strategy on acceptance of the data and the standards expected when conducting studies after approval or trying to collect RWD to analyse and create RWE.
“George Clinical is excited to see these standards so clearly outlined by the Food and Drug Administration,” Sean Hart, Managing Director USA and Global Head of Late Phase Studies said following the publication. “George Clinical continues to globally provide the top post approval programs collecting real world data for our commercial partners and our parent company, The George Institute for Global Health. We are excited to apply these definitions and guidance to ensure that we meet these standards and apply the definitions in our local and global programs and their evidentiary needs.”
George Clinical enjoys a relatively uncommon genesis for a major CRO. While many CROs build their practice, networks and global resource from an increasing portfolio of smaller, early phase studies sponsored predominantly by biotech and later graduate with larger global late-phase or RWE studies. George Clinical however, inverted this approach with a dominant scientific presence in late phase studies built from day one to provide operational expertise to some of the largest late-phase/RWE clinical trials ever conducted.
While George Clinical teams cut their teeth in the world of late phase, RWD/RWE trials, their breadth of experience has grown over the past fifteen years to a CRO targeted enough to provide face-to-face operational services for all trial phases successfully, yet global and fully capable to execute the most sophisticated, multi-national late-phase/real-world data trials.