Aetion®, a leader in real-world evidence (RWE) technology and analytics, has published ‘SURF,’ a tool intended to assist sponsors in assessing the feasibility of utilizing real-world data (RWD) to provide evidence supporting an effectiveness claim in a U.S. Food and Drug Administration (FDA) application. The FDA has been increasingly open to RWE, which is particularly useful when traditional randomized controlled trials (RCTs) are not feasible, and there is an urgent public health need. The SURF tool, developed by Aetion based on their experience and review of FDA guidance and RWE uses, aims to help sponsors determine early on whether the RWE approach is worth pursuing, considering the time and cost associated with studying design and data feasibility. The tool adds to a set of resources developed by Aetion to support the effective use of RWE in regulatory applications.
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[Source: PR Newswire, August 25th, 2023]