Articles and Insights About Wearables for Clinical Trials

Articles by Kate Lyden

Kate Lyden

Kate Lyden, PhD., VP Science and Research at VivoSense. She holds degrees in Kinesiology and Applied Physiology and has extensive research experience developing, validating, and using wearable sensors.

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Recent Articles


VivoSense Joins DiMe Physical Activity Project

Posted by Kate Lyden on October 31, 2022

We are excited to announce our participation in DiMe's Physical Activity, the latest digital clinical measures project. In partnership with the Digital Medicine Society (DiMe) and other leaders in the field, we are developing a core set of digital measures for tracking patients’ physical activity across any therapeutic area.

Clinicians, researchers, and drug developers need to have a shared baseline of digital measures to improve our patients’ health, regardless of their disease or condition. By taking an omni-therapeutic approach, we believe we can reduce time and risk, speeding the development of new therapies to market. Read more about the project.

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Digital Biomarkers: Pandemic Impact, Barriers, Trends, Hype, and Hope

Posted by Kate Lyden on April 26, 2022

Joao Bocas, a keynote speaker and social media influencer for digital health technology, interviewed Kate Lyden, Chief Science Officer at Vivosense, to discuss trending topics surrounding the transformation of moving clinical trials into the real world. They talked about the impact of the pandemic, barriers to adoption, therapeutic areas that can benefit, and some of the hype and hope of novel digital biomarker development.

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Catalyze Digital Biomarker Innovation Through Collaboration

Posted by Kate Lyden on January 27, 2022

Industry and academia each play important roles in advancing wearable technologies and digital biomarkers to develop life-changing drugs and therapies. Still, successful relationships between the two groups are not nearly as prevalent as they could – or should – be. In this presentation, Kate Lyden, VivoSense Chief Science Officer, discusses the motivation for academia and industry to work together, where the overlap lies, and opportunities for moving forward together.

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Digital Biomarkers: Current Limitations and Future Outlook

Posted by Kate Lyden on December 23, 2021

There’s an undeniable push to drive innovation for a new age of precision medicine. At the 2021 Digital Biomarkers & Digital Measurements Summit, Kate Lyden, VivoSense Chief Science Officer, joined a panel of experts to discuss the future of digital biomarkers and advancing medicine toward a patient-oriented, decentralized, tech-enabled approach. Here is a quick snap-shot of her key takeaways.

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The Value of Exploratory Endpoints in Early Phase Clinical Trials

Posted by Kate Lyden on October 5, 2021

Drug development and clinical care models continue to take a more patient-centered approach. Putting the patient at the center of all phases of medicine is a shift initiated by the FDA. Systematic governance and policy development are currently underway.

A key component to supporting this paradigm shift is the use of real-world evidence collected with wearable sensors. Despite their enormous potential and the pharmaceutical industry’s enthusiasm for their incorporation into drug trials, the majority of digital clinical measures continue to require development – primarily, context-specific clinical validation.

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Using Wearable Sensors to Assess Sleep-Related Outcome Measures

Posted by Kate Lyden on February 5, 2021

Sleep-related outcome measures obtained with wearable sensors provide valuable data in clinical trials. In addition to reducing the tremendous burden and cost associated with the traditional methods of assessing sleep, they offer an opportunity to take a more in-depth, day-to-day look into how a patient feels, functions, and survives.

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A Look into the Future of VivoSense V3 Endpoint Development

Posted by Kate Lyden on 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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Biomarkers vs. Clinical Outcome Assessments (COA) vs. Endpoints

Posted by Kate Lyden on October 29, 2020

COAs, Biomarkers, and Endpoints, Oh My!

Establishing a common vocabulary accelerates progress by enabling effective communication and collaboration among stakeholders and facilitating cross-study comparisons and evidence harmonization. However, when we work with clinical researchers, they often use the words biomarkers, clinical outcome assessments (COA’s), and Endpoints interchangeably, but technically they mean different things.

I’m confident that my amazing team members often think I’m crazy when I deliberate or nitpick over the use of a single word. The point is words matter, especially in science and definitely in a new field like digital medicine. As this field evolves, definitions and key terms must be used consistently to reduce the hindrance of evaluating and interpreting scientific evidence.

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Creating a Data Quality System for Digital Biomarker Development

Posted by Kate Lyden on August 13, 2020

Wearable technologies and their associated informatics platforms gather, store, and process vast amounts of health-related, real-world data. These datasets can be some of the most complex used in health research. If the end-goal is to provide evidence in regulatory decision making, implementing well-defined practices to demonstrate sufficient data quality and fidelity is a must.

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Digital Biomarker Discovery: All for One, Not One for All

Posted by Kate Lyden on May 21, 2020

When it comes to the development and discovery of novel digital biomarkers in clinical trials, one size does not fit all. Patrick Hankey, our head of strategic business development, sums up the problem very well when he explains, “If you have seen one clinical trial, you have seen one clinical trial.” In this article, we describe what we mean by “one size does not fit all” within the context of digital biomarker discovery and provide examples of how this principle is particularly relevant to the validation of wearable sensor solutions.

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