Real-World Evidence: Sponsors Will Need Prospective Process Early In Development
US FDA's approach to clinical trial replication project may offer tips for sponsors looking to use real-world evidence to support drug development.
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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.
As more sponsors begin using RWE, the agency is establishing procedures and training to ensure assessors consistently apply policies.
Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.