By Tyler Guthrie, ActiGraph Lead of Scientific Affairs and Data Management
The most critical factor to the success of any clinical research study is participant adherence to the study design. As the use of wearable technologies becomes more and more mainstream in clinical research, it presents unique challenges and considerations to ensure proper protocol adherence with minimal missing data. Many of these considerations have to do with the usability of the wearables and the platform required for data collection. That’s why the FDA has placed usability at the center of its new draft guidance on digital health technologies (DHTs).
In this article, discover practical guidance for optimizing wearables adherence during a study. In our experience, device specifications, protocol design, and adherence monitoring are the top three factors that sponsors should prioritize when planning a study.