Articles and Insights About Wearables for Clinical Trials

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.

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.

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.

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.

Advances in AI, digital technology, and wearable devices have played a vital role in accommodating the social distancing restrictions during the COVID-19 pandemic. Emerging digital clinical measures enable clinicians and researchers to maintain continued support for patients and healthcare systems. However, organizational barriers often slow the advancement of the adoption of digital clinical measures. Here are some ways experts can help you overcome the obstacles.

As demand for preventive and precision healthcare evolves, the need for a new class of broadly applicable, precise, and accurate biomarkers exists. This approach gives clinicians and researchers the ability to monitor patients in the real world and discover the most effective treatment strategies. Regardless of your stage of adoption, digital biomarker experts can help.

Digital health technologies have the potential to transform clinical drug development. They can collect continuous, high-resolution data in patients’ real-world environments for extended periods of time, providing researchers with an unprecedented level of insight into patients’ physiological and behavioral states. These types of data may more accurately describe a patient’s experience and enable previously unattainable scientific undertakings.

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.