Tag: digital biomarkers FDA guidance

Expanded Role of Wearables in U.S. Clinical Trials

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Expanded Role of Wearables in U.S. Clinical Trials The Growing Role of Wearable Devices in U.S. Clinical Research Introduction Wearable technologies such as smartwatches, biosensors, continuous glucose monitors, and electronic patches are transforming the conduct of clinical trials in the United States. By capturing real-time physiological and behavioral data, wearables enable decentralized and patient-centric trial…

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Clinical Trials in USA, Country-Specific Clinical Trials

FDA Approach to Digital Endpoints in U.S. Clinical Trials

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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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Clinical Trials in USA, Country-Specific Clinical Trials