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Expanding ways to generate evidence can lead to an array of benefits for medical product development, including more diverse patient representation and the potential to expedite the availability of safe and effective therapies. As data sources outside of traditional clinical trials become more accessible and methods for analyzing such sources become more robust, there are further opportunities to use real-world data (RWD) to evaluate safety and support evidence of effectiveness.
Submissions to the U.S. Food and Drug Administration that incorporate the use of RWD are rapidly increasing, particularly in the field of oncology. When selecting a data source, RWD should be fit-for-purpose for the prespecified scientific study objective. To effectively review a study proposal, there should be sufficient information to allow the FDA to provide useful feedback to sponsors. Sponsors should consult relevant FDA guidance documents for specific recommendations regarding studies using RWD.
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