Articles and Insights About Wearables for Clinical Trials

DHT Validation

Creating a Common Understanding of Analytically Validated DHTs

 Kate Lyden, PhD

DATAcc announced the release of the Analytical Validation Library on May 23, 2023! Kate Lyden, Ph.D. and VivoSense CSO collaborated with other industry leaders to show ‘what good looks like’ regarding high-quality analytical validation. As new DHTs come online, industry-wide standards must be developed in tandem to ensure their ability to measure, detect or predict a clinical state.

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Essential Steps to FDA Approval for Digital Biomarkers [Infographic]

 Kate Lyden, PhD

The FDA is working toward modernizing its framework for advancing the promise of digital health tools. Scientists and researchers can be creative and innovative using real-world data collected from wearable sensors and connected technologies. The key is to demonstrate well-defined practices to demonstrate sufficient data quality and fidelity to provide evidence in regulatory decision-making.

In this infographic, we outline the essential steps required to get FDA approval for digital biomarkers.

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Wearable Sensors and Validating Outcome Measures in Clinical Trials

 Dudley Tabakin

In this Hitlab panel discussion, VivoSense CEO Dudley Tabakin and Industry Principal Paul Sonnier discuss validating digital endpoints for their delivery in clinical trials using a patient-first approach that substantiates the efficacy or performance of their treatment.

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A Look into the Future of VivoSense V3 Endpoint Development

 Kate Lyden, PhD

We really like validation: in fact, you might say we take it personally. It’s the foundation of everything we do. We are excited to report that we’re nearing the completion of a study that we believe will greatly expand the possibilities of digital outcome measures in clinical trials.

The research includes steps 1 and 2 of the V3 framework, verification and analytical validation. The outcome will be validated, machine learning algorithms to derive novel, real-world measures of physical function and mobility from wearable kinematic sensors (e.g., accelerometers, gyroscopes). Here’s an overview of our approach to the study and development efforts.

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