Articles and Insights About Wearables for Clinical Trials

Alzheimer’s disease (AD) is a devastating neurodegenerative disease that progresses to impact every dimension of a patient’s life. With no cure and limited options to manage symptoms, research is underway to develop drugs that impact the most burdensome aspects of AD: memory problems and the ability to function independently.

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.

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.

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.

In this Hitlab panel discussion, VivoSense CEO Dudley Tabakin and Industry Principal Paul Sonnier discuss validating digital endpoints for their delivery in clinical trials using a patient-first approach that substantiates the efficacy or performance of their treatment.

Vivosense is pleased to announce that Ieuan Clay has joined the company as Director of Science. He brings extensive knowledge in developing and validating novel digital measures gained across experiences in industry, healthtech and academia.

VivoSense, an agile end-to-end digital clinical endpoint solutions company developing digital endpoints from wearable sensors with their proprietary AI-enabled software platform is proud to join an alliance of over one hundred and twenty life sciences and healthcare organizations that seek to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The Decentralized Trials & Research Alliance (DTRA), is uniting industry stakeholders, including healthcare companies, regulators, patient groups, research organizations and technology providers with a singular mission to make clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research.

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.

Pharmaphorum interviewed VivoSense CEO Dudley Tabakin and new board members from Xontogeny and Debiopharm to discuss how VivoSense’s recent $25M Series A Financing round will help scale up VivoSense® software and accelerate the use of wearable sensors data in 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.