Frontiers In Real-World Evidence: US FDA Partners With Syapse To Explore Sources Beyond Electronic Records
Oncology Center of Excellence will collaborate with the health data company to explore RWE sources for precision medicine.
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FDA's principal deputy commissioner, who used to work in the real-world evidence field, said momentum is building, but more successful use cases are needed.
The concept of missing data is very different when analyzing real-world evidence compared to a randomized clinical trial.
As more sponsors begin using RWE, the agency is establishing procedures and training to ensure assessors consistently apply policies.