Articles and Insights About Wearables for Clinical Trials

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.

The adoption of wearables into clinical trials is fostering innovative ideas about novel digital biomarker development. The following articles discuss strategies for developing respiratory endpoints using real-world data and a patient-centered approach. Learn more and advance ideas for your next research project!

In this video, Dudley Tabakin, VivoSense CEO, shares an example of how rare disease researchers can use wearable sensors to develop digital clinical measures to improve patient outcomes. He discusses our approach to developing outcome measures from ECG Derived Respiration (EDR) to discover novel respiratory endpoints for Rett Syndrome, working with Rett Syndrome Research Trust.

Millions of people across the globe struggle with neurodegenerative diseases every day. Neurodegenerative diseases are characterized by a breakdown of the central and peripheral nervous systems and cause progressive deterioration of a normally functioning human body. However, a significant challenge in studying neurodegenerative diseases is that direct measurements of neurological systems are invasive and expensive.

Wearable sensors can be used to understand disease progression and manifestation by measuring physical symptoms and physiological outcomes.

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.

Physical function and mobility are relevant to virtually all clinical indications and are significant determinants of an individual’s quality of life. Because of this, function and mobility are often assessed in clinical trials using subjective questionnaires or in clinic performance tests, but these assessments may not reflect a patient’s lived experience. Wearable sensors provide an opportunity to move assessments of function out into the real world to measure how patients feel and function in their own environments.

Respiratory abnormalities characterize a variety of disorders. In addition to physical disorders, ventilation is profoundly affected by mental and psychophysiological states, including stress, anxiety, and panic disorder. Let’s take a look at respiratory-related health issues and the promising wearable technology available to assess respiratory outcome measures in real-world settings.

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.

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.

To drive scientific progress and increase digital medicine acceptance, the Digital Medicine Society (DiMe) has created The Playbook: Digital Clinical Measures, “ the essential industry guide for successfully developing & deploying digital clinical measures across clinical research, clinical care, and public health.”

We are excited to be included in the Tour of Duty, a team of experienced tech, pharma, clinical leaders, regulators, and patient advocates driving the adoption of a shared foundation for the digital health field.