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Example of New Digital Biomarker Development

The Case for Real-Time, Real-World Data

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 VP of Science and Research, 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

Explore wearable sensor solutions for your regulated clinical trial.