Example of New Digital Biomarker Development

The landscape of wearable sensors in clinical trials has proven difficult to navigate for many, including sponsors and vendors.

Collaboration around the development of digital endpoints with a focus on data quality, validation, compliance, and clinical utility is required to extract the most from new digital technologies.

In this 20-minute presentation, VivoSense lead scientist, Kate Lyden, PhD., and Jeremy Wyatt, President of ActiGraph, discuss:

1. Characteristics of clinically meaningful endpoints
2. The data behind developing a novel digital biomarker called the Best 6 Minute Effort (B6ME) an outcome assessment that can augment the in-clinic 6 Minute Walk Test (6MWT) with real-world data collected from a wearable sensor
3. Steps for future development

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