FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Collaboration Pulls RWE in Clinical Oncology Trials

Aug. 21, 2019
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Syapse and the FDA’s Oncology Center for Excellence are collaborating on ways to better use real-world evidence (RWE) to support the agency’s regulatory process.

The collaboration will focus on regulatory questions about testing and treatment patterns, dosing and safety, and outcomes, and will investigate multiple sources of RWE in addition to electronic health records and registries.

Syapse’s oncology researchers from its Learning Health Network will participate in the effort.

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