While traditional endpoints and biomarkers are still necessary for FDA submission and regulation, the advent of digital tools has presented the opportunity to revolutionize the data capture method — specifically, the ability to collect more specific, relevant data points or digital biomarkers. Novel digital endpoints gathered via wearables, small devices, or algorithms hold great promise for clinical trials. As digital endpoints continue to undergo validation and yield effective results, pharmaceutical and medical device companies can work towards a future where these outcomes can replace traditional in-clinic endpoints for FDA submission and therapeutic regulation. World BI’s Webinar on Developing Novel Digital Endpoints for better decision making discusses pragmatic criteria for the selection, technical validation, and clinical validation of novel digital endpoints and provides recommendations for future work and collaboration.
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Executive Director, Head Of Clinical Development Quality Performance And Risk Management
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