We support FDA’s ongoing work to facilitate use of real-world data (RWD) and real-world evidence (RWE), which will add to the understanding of medical product safety and effectiveness and benefit patients.
FDA and Congress have taken important steps to advance the use of RWD/E. The 21st Century Cures Act called on FDA to publish a framework for the use of RWE for regulatory purposes, and FDA has taken steps to implement this provision by publishing a draft framework in December 2018 and issuing valuable guidance. The RWE Alliance appreciates FDA’s commitment to realizing the full potential of fit-for-purpose RWD to generate RWE that will advance the development of medical products and enhance regulatory decision making. We share this goal, as these efforts will ultimately benefit patients.
We believe that fit-for-purpose RWE can play an important role in the review of medical products—and can provide or contribute to substantial evidence of effectiveness. As real-world data and analytics organizations with a common interest in harnessing the power of RWE, we stand ready to provide partnership, expertise, and perspective as the Agency further develops RWD/E policy, and as Congress considers additional action in this space.
As part of these efforts, the RWE Alliance will work to promote utilization of RWE across therapeutic areas to ensure that more patients will benefit.