Diabetes Drug Safety Might Be Best Assessed With Real-World Data
Meta-analysis published in JAMA suggests registry-based studies could be alternative to large cardiovascular outcomes trials.
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FDA, industry and patient advocates all want studies to move beyond HbA1c, but still need to develop common thresholds and definitions to support patient-reported outcomes in diabetes drug development.
Manufacturers are enthusiastic about the possibility of using real-world evidence to expand product indications. But even with new resource support, they know it's a long road to get there.
Regulators pledge to explore the use of real-world evidence, strengthen the patient's voice in drug review, and boost the agency's postmarketing surveillance abilities as part of sixth round of user fee program with industry.