Articles and Insights About Wearables for Clinical Trials

Digital Biomarkers

Essential Steps to FDA Approval for Digital Biomarkers [Infographic]

Posted by Thomas Leonard on September 17, 2020

In 2018, Scott Gottlieb, M.D., Commissioner of Food and Drugs, announced efforts to transform the FDA’s approach to digital health, including “tools such as digital biomarkers for early disease diagnosis, or using data from EHRs to enable pragmatic clinical trials at the point of care.” He went on to say, “These kinds of tools can help us make drug and device development more predictable, efficient and more reflective of patients’ real-world experience.”

While the FDA is working toward modernizing its framework for advancing the promise of digital health tools, there is a long way to go. Still, scientists and researchers can be creative and innovative using real-world data collected from wearable sensors and connected technologies. The key is to demonstrate well-defined practices to demonstrate sufficient data quality and fidelity to provide evidence in regulatory decision making.

In this infographic, we outline the essential steps required to get FDA approval for digital biomarkers.

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Creating a Data Quality System for Digital Biomarker Development

Posted by Kate Lyden on August 13, 2020

Wearable technologies and their associated informatics platforms gather, store, and process vast amounts of health-related, real-world data. These datasets can be some of the most complex used in health research. If the end-goal is to provide evidence in regulatory decision making, implementing well-defined practices to demonstrate sufficient data quality and fidelity is a must.

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Benefits of Using Wearable Sensors in Clinical Trials

Posted by Dudley Tabakin on June 26, 2020

The study of human health in real-world, everyday environments is necessary to advance knowledge and discovery. Wearable sensors make this possible by providing customized body-worn monitoring and analysis solutions that are rooted in scientific foundations. Here is a list of the advantages of using wearable technologies in your clinical trials.

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Good Data is Essential in Digital Biomarker Development

Posted by Dudley Tabakin on June 4, 2020

Good data is more important than big data in the development of digital biomarkers. Big data is often sold as the solution to all digital data analyses and 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.

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Digital Biomarker Discovery: All for One, Not One for All

Posted by Kate Lyden on May 21, 2020

When it comes to the development and discovery of novel digital biomarkers in clinical trials, one size does not fit all. Patrick Hankey, our head of strategic business development, sums up the problem very well when he explains, “If you have seen one clinical trial, you have seen one clinical trial.” In this article, we describe what we mean by “one size does not fit all” within the context of digital biomarker discovery and provide examples of how this principle is particularly relevant to the validation of wearable sensor solutions.

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Digital Biomarker Discovery Must be Hypothesis-Driven

Posted by Kate Lyden on May 6, 2020

The first guiding principle to the development and discovery of novel digital biomarkers is hypothesis-driven research. In this article, we will describe our approach and provide examples of how we use this principle to ensure robust digital biomarker development.

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An Introduction to the Foundation of Digital Biomarker Development

Posted by Dudley Tabakin on April 9, 2020

The future of clinical trials involves real-world data collected from wearable sensors and connected technologies. Pharmaceutical companies are investing heavily in digital innovation; however, the adoption of digital biomarkers remains slow. To overcome the challenges associated with high frequency, real-world data, and for digital solutions to realize their potential in clinical trials, we must develop robust and systematic approaches to their use.

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Developing Digital Biomarkers in Clinical Trials and Healthcare Delivery

Posted by Patrick Hankey on May 1, 2017

The practice of medicine and medical research is undergoing a rapid digital revolution transforming healthcare into a science of data analytics. The term Digital Health has entered the lexicon as we increasingly understand and describe medicine in terms of data generated by wearable physiological sensors, genetic sequencing and medical imaging. Rock Health, a venture fund dedicated to the founding and growth of Digital Health companies, recently published a report on the data driven transformation of healthcare, in particular highlighting the urgent need to develop digital biomarkers. Digital biomarkers are the medical signal or signatures contained in the vast data sets generated by the ever increasing use of leading edge medical technologies.

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