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Activity Number: 247 - Wearable/Implantable Device Data in Clinical Trials
Type: Invited
Date/Time: Tuesday, August 4, 2020 : 1:00 PM to 2:50 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #309427
Title: Digital Health Technology: Use in Clinical Investigations to Evaluate Clinical Benefit in Patients
Author(s): Ebony Dashiell-Aje*
Companies: BioMarin Pharmaceutical Inc.
Keywords: digital health technology ; clinical investigations ; clinical benefit ; technology-derived endpoints; regulatory decision-making

Incorporating digital health technology (e.g., mobile technology, wearable devices) into the design and conduct of clinical trials has the potential to provide information that is reflective of how patients feel and function in the real world to help complement traditional COA measures. Technology-derived endpoints may help capture patient experiences beyond what can be readily observed or reported in clinic and research settings, providing a meaningful way of assessing outcomes that are important to patients. While there is increasing interest in the use of digital health technology-based assessments, further discussion is necessary to determine how to implement these assessments in clinical trials and how to analyze the data to support regulatory decision-making. This session will focus on discussing measurement considerations for using digital health technology-based assessments in a clinical trials. Key discussion topics include: determining what you want to measure (e.g., concept of interest); deriving endpoints to be examined; and digital health technology tool design, implementation, and data analysis.

Authors who are presenting talks have a * after their name.

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