At the 5th Annual Clinical Trials IoT & Digital Endpoints Forum, Kate Lyden, Lead Scientist at VivoSense, shared an example of one of the first regulated clinical trials that used a wearable sensor to monitor or measure a digital biomarker in a patient's home setting. Researchers were aiming to improve the outcome of patients with breathing abnormalities associated with the rare disease, Rett syndrome.
The data has been submitted to the FDA for review and approval with a sensor identified digital biomarker as primary and secondary endpoints.
"I think that we're finally getting to a point where the software, the data analytics, and the regulatory framework are catching up to these hardware devices. We're now more equipped than ever to take clinical trials out of the clinic and move them to a patient's home or move them to a real- world environment." ~ Kate Lyden, Lead Scientist, VivoSense
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