Articles and Insights About Wearables for Clinical Trials

We are excited to announce our participation in the Digital Medicine Society's (DiMe) latest digital clinical measures project, Core Measures of Sleep. In partnership with the Digital Medicine Society and other leaders in the field, we are paving the way for better approaches to collecting, analyzing, and interpreting sleep data.

Movement and mobility-related information collected passively and continuously from digital health technologies (DHTs) as patients go about their daily lives can significantly advance our understanding of patient functioning. The Best 6-Minute Effort (B6ME)™ is a novel outcome measure that captures the maximum effort exerted by a patient as they go about their typical daily life, providing insight into their lived experience.

Here's an overview of what B6ME™ is and how it augments the 6MWT to provide additional granularity of patient functioning and novel movement and mobility-related outcomes.

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.

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.

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.

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.

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.

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, wearable technology offers an opportunity to take a more in-depth, day-to-day look into how a patient feels, functions, and survives.

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.

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.