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Wearable Sensors

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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Commonly Used Wearable Sensors in Clinical Trials

Posted by Patrick Hankey on August 4, 2020

Wearable sensors provide sophisticated insights into patients’ real-world behavior and functioning in clinical trials and healthcare settings. Drug development researchers, regulators, payors, and patients want to see meaningful, valid insights enabled by them. In this guide, we break down the following commonly used wearable sensors: including what they do, their benefits, and other important considerations for incorporating them into your clinical trial:

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Getting Started Using Wearable Sensors for Clinical Research

Posted by Patrick Hankey on July 23, 2020

Wearable sensors and digital technology offer great potential in understanding the patient experience in clinical trials. The collection of rich data, captured in real-world settings, provides deep insights into our understanding of medical treatment effects. With so many factors to consider, however, it is no simple task to make this choice. Here are some key considerations for getting started using wearable sensor data collection for clinical research.

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