2024, Scientific Reports
Traditional assessments of mobility, such as the 6-Minute Walk Test (6MWT), 10-Meter Walk Test (10MWT), or T25-FW, provide valuable but episodic measures of functional capacity. Besides, these in-clinic evaluations often fail to reflect how patients function in their everyday environments.
By contrast, digital endpoints offer continuous and objective insights into patients mobility and behavior in their daily environments. They can also reveal subtle and clinically meaningful dimensions, such as fatigability, that remain invisible in traditional, clinic-based testing.
Digital endpoints have the potential to provide more reliable and sensitive assessments than traditional methods, enabling shorter study durations and reduced sample sizes. They also position objective patient data at the core of drug development. Digital endpoints enable precise quantification of disease progression and severity.
Realizing this potential requires the use of appropriate wearable technologies along with disease-specific analytical and clinical validation of digital endpoints to ensure accuracy, robustness, and regulatory compliance.
At Sysnav Healthcare, the development of regulatory-grade digital endpoints begins with building robust disease models informed by insights from patients and clinicians. From these models, we define digital variables that capture key concepts of interest and validate them through rigorous analytical and clinical studies to ensure their robustness, reliability, and clinical relevance.
We have achieved an exceptional validation success rate across 20 disorder areas.
Here is some of our published work on digital endpoint development and validation.
Sysnav Healthcare provides dedicated scientific support to ensure that digital endpoints are seamlessly integrated into clinical trials. Our team collaborates with sponsors to define relevant variables, select appropriate endpoints, and align study methodology with regulatory and scientific standards.
