Abstract

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 measurement 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.

中文翻译：

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用于衡量帕金森病临床试验药物疗效的数字健康技术：监管视角

摘要

数字健康技术 (DHT)，包括可穿戴和环境传感器、摄像机和其他电子工具，为测量帕金森病的运动和功能提供了新的机会。与当前的疾病评估标准 (MDS-UPDRS) 相比，DHT 可能为更频繁地客观测量疾病表现的持续时间、严重程度和频率提供新的可能性，这可能比定期就诊提供更多信息。然而，DHT 测量只有在准确、可靠和具有临床意义的情况下才具有科学和医学用途。DHT 性能的验证和验证，也称为分析验证和临床验证，对于确保测量的准确性和精密度以及结果的特异性非常重要。