FDA Approach to Digital Endpoints in U.S. Clinical Trials
FDA Approach to Digital Endpoints in U.S. Clinical Trials FDA’s Approach to Digital Endpoints in Clinical Trials: U.S. Regulatory Perspectives Introduction The rise of digital health technologies has revolutionized clinical research in the United States, enabling the collection of continuous, real-world data through wearables, sensors, smartphones, and electronic patient-reported outcomes (ePROs). These digital endpoints are…
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