Articles and Insights About Wearables for Clinical Trials

DHT Validation

Creating a Common Understanding of Analytically Validated DHTs

 Kate Lyden  July 13, 2023

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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Wearable Sensors and Validating Outcome Measures in Clinical Trials

 Dudley Tabakin  September 22, 2022

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  December 10, 2020

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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Essential Steps to FDA Approval for Digital Biomarkers [Infographic]

 Dudley Tabakin  September 17, 2020

In 2018, Scott Gottlieb, M.D., Commissioner of Food and Drugs, announced efforts to transform the FDA’s approach to digital health, including “tools such as digital biomarkers for early disease diagnosis, or using data from EHRs to enable pragmatic clinical trials at the point of care.” He went on to say, “These kinds of tools can help us make drug and device development more predictable, efficient and more reflective of patients’ real-world experience.”

While the FDA is working toward modernizing its framework for advancing the promise of digital health tools, there is a long way to go. Still, 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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