Articles and Insights About Wearables for Clinical Trials

Digital Biomarkers

Scope 2024: Driving Innovation in Clinical Trials and Digital Health

 Rob Wilson

At the 15th Annual SCOPE Meeting in Orlando, “Driving Innovation in Clinical Trials and Digital Health,” representatives from across the clinical trial ecosystem shared case studies and described their commitment and approach to improving patient health through better clinical trials. 

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Why You Should Include Digital Endpoints in Clinical Trials

 Jen Blankenship, PhD

See how research teams can start using wearables to identify novel digital biomarkers to efficiently generate real-world patient evidence in clinical trials.

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Key Learnings about Digital Measurement in Pediatric Research

 Dudley Tabakin

In May 2022, UCB launched a digital health roundtable series to explore the many diverse ways technology can benefit patients. In the third Roundtable, Emily Lewis (Digital Business Transformation, Neurology, UCB) convened an expert panel, including Dudley Tabakin, VivoSense CEO, to discuss the field of pediatric digital measurement to unpack key learnings from deployments to date, challenges, opportunities and the need for its translation into care. Watch the full video to hear insights from all four esteemed panelists.

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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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Good Data is Essential in Digital Biomarker Development

 Dudley Tabakin

Good data is more important than big data in developing digital biomarkers. Big data is often sold as the solution to all digital data analyses and is touted to revolutionize healthcare in the coming years. However, the problem with a superabundance of data is that digital biomarker development becomes a fishing expedition, and the catch may not be relevant to the question. Without a hypothesis (often the case in biomarker development with big data), accurate results may be too low to use in a clinical trial or, even worse, divergent with no findings.

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Stijn Rogiers Interview About Accelerating Digital Endpoints

 Dudley Tabakin

SAS Principal Industry Consultant Stijn Rogiers interviewed VivoSense CEO Dudley Tabakin about the uptake in decentralized clinical trials in response to the ongoing disruptions caused by the Coronavirus pandemic of 2020. As trials move toward decentralization, new processes and strategies are required to effectively collect and analyze patient data in a meaningful and validated way. Here are a few key takeaways from their conversation.

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Catalyze Digital Biomarker Innovation Through Collaboration

 Kate Lyden, PhD

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

 Kate Lyden, PhD

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

 Kate Lyden, PhD

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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How Digital Data Impacts the Development of New Treatments

 Patrick Hankey, PhD

Digitally connected devices are transforming the way we treat and manage health conditions. They also introduce and improve participant access, engagement, and outcome measurements in clinical trials. Here’s a look at how digital data is paving the way for advances in treatments and recovery.

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