Open AccessDigital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective
Author(s) -
Leonard Sacks,
Elizabeth Kunkoski
Publication year - 2021
Publication title -
journal of parkinson's disease/journal of parkinson's disease (online)
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.747
H-Index - 45
eISSN - 1877-718X
pISSN - 1877-7171
DOI - 10.3233/jpd-202416
Subject(s) - clinical trial , perspective (graphical) , disease , parkinson's disease , wearable computer , drug trial , medicine , digital health , computer science , wearable technology , physical medicine and rehabilitation , medical physics , clinical disease , physical therapy , artificial intelligence , pathology , health care , embedded system , economics , economic growth
Digital health technology (DHT), including wearable and environmental sensors, video cameras and other electronic tools, has provided new opportunities for the measurement of movement and functionality in Parkinson’s disease. Compared to current standards for evaluation of the disease (MDS-UPDRS), DHT may offer new possibilities for more frequent objective measurements of the duration, severity and frequency of disease manifestations over time, that may provide more information than periodic clinic visits. However, DHT measurements are only scientifically and medically useful if they are accurate, reliable and clinically meaningful. Verification and validation, also known as analytical validation and clinical validation, of DHT performance is important to ensure the accuracy and precision of measurements, and the specificity of findings. Given the wide range of clinical manifestations associated with Parkinson’s disease and the many tools and metrics to assess them, the challenge is to identify those that may represent a standard for use in clinical trials, and to confirm when digital measurements succeed or fall short of capturing meaningful benefits during drug development.