Articles and Insights About Wearables for Clinical Trials

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.

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 into the real world to measure how patients feel and function in their everyday environments.

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.

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.

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, 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.

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.

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.