Real-World Evidence: US FDA Framework Emphasizes Data Fitness And Study Quality
Agency’s approach to assessing real-world evidence for effectiveness will be guided by three key principles: fitness for use of the underlying data, adequacy of the study design, and satisfactory monitoring and data collection.
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Rigorous planning and a multidisciplinary team including database experts and healthcare specialists with local knowledge are vital to effective real-world evidence, white paper shows.
Methodological problems with RWE submissions for approved applications may give sponsors ‘a little bit of a pause’ as they work through data selection and analytical issues, Aetion’s Jeremy Rassen says. CDER’s Janet Woodcock says it is easier to use RWE when treatment effects are large.
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.