Together, Syapse and the FDA will examine precision oncology’s use of real-world evidence to determine testing and treatment patterns, dosing and safety, and patient outcomes. This research will include identifying sources of real-world evidence, including EHRs, claims data and molecular testing labs, and assessing the viability of using this multisource data to develop novel medical treatments, rather than relying on traditional clinical trials.
“Advancing a deeper understanding of real-world endpoints and analytical methodologies is critical to assuring that all stakeholders can have confidence in the quality of evidence produced and accelerating the use of RWE in regulatory decision-making,” Jonathan Hirsch, founder and president of Syapse, said in a statement.
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