Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
J Parkinsons Dis. 2021;11(s1):S111-S115. doi: 10.3233/JPD-202416.
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.
数字健康技术（DHT），包括可穿戴设备和环境传感器、摄像机和其他电子工具，为帕金森病运动和功能的测量提供了新的机会。与目前评估疾病的标准（MDS-UPDRS）相比，DHT 可能为更频繁地对疾病表现的持续时间、严重程度和频率进行客观测量提供了新的可能性，这些测量可能比定期的临床就诊提供更多的信息。然而，如果 DHT 测量结果准确、可靠且具有临床意义，那么它们才具有科学和医学上的意义。为了确保测量的准确性和精密度，以及研究结果的特异性，对 DHT 性能进行验证和确认，也称为分析验证和临床验证，是很重要的。鉴于帕金森病的临床表现多种多样，且有许多工具和指标来评估这些表现，挑战在于确定哪些指标可能代表临床试验的标准，并在药物开发过程中确认数字测量在捕捉有意义的疗效方面的成功或不足。
