Articles and Insights About Wearables for Clinical Trials

Wearable Sensors

Creating a Common Understanding of Analytically Validated DHTs

 Kate Lyden, PhD

DATAcc announced the release of the Analytical Validation Library on May 23, 2023! Kate Lyden, Ph.D. and VivoSense CSO collaborated with other industry leaders to show ‘what good looks like’ regarding high-quality analytical validation. As new DHTs come online, industry-wide standards must be developed in tandem to ensure their ability to measure, detect or predict a clinical state.

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The Value of Exploratory Endpoints in Early Phase Clinical Trials

 Kate Lyden, PhD

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.

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Consumer-Grade Activity Trackers Place in Clinical Research

 Patrick Hankey, PhD

Wearable sensor devices are an essential element for data collection. As their use is rapidly growing, so is the debate whether consumer or medical-grade wearable sensors are fit for purpose in clinical trials.

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How Digital Data Impacts the Development of New Treatments

 Patrick Hankey, PhD

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.

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Understanding Wearable Sensor Types and Wear Location

 Patrick Hankey, PhD

When deploying wearable sensors in clinical trials, it is essential to understand how they should be positioned on the body. The objective is to maximize the quality of the signal while minimizing the burden on patients and maintaining their comfort. Sensor wear position also impacts the accuracy and precision of digital clinical outcome measures. Here's an overview of some common wearable sensors types and wear locations.

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Digital Health Technologies in Clinical Drug Development

 Dudley Tabakin

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.

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Commonly Used Wearable Sensors in Clinical Trials

 Patrick Hankey, PhD

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

 Patrick Hankey, PhD

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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Benefits of Using Wearable Sensors in Clinical Trials

 Dudley Tabakin

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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An Introduction to the Foundation of Digital Biomarker Development

 Dudley Tabakin

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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