Science Blog

Overcoming the Barriers to Adopting Digital Clinical Measures

Posted by Patrick Hankey on May 27, 2021

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.

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How Experts Can Help Your Organization Adopt Digital Biomarkers

Posted by Patrick Hankey on May 20, 2021

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.

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Measuring Respiratory-related Outcomes with Wearable Sensors

Posted by Dudley Tabakin on April 8, 2021

Respiratory abnormalities characterize a variety of disorders. In addition to physical disorders, ventilation is profoundly affected by mental and psychophysiological states, including stress, anxiety, and panic disorder. Let’s take a look at the highlights of respiratory-related health issues and the promising wearable technology available to assess respiratory outcome measures in real-world settings.

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Understanding Wearable Sensor Types and Wear Location

Posted by Patrick Hankey on April 1, 2021

When deploying wearable sensors in clinical trials, it is essential to understand how these are positioned on the body. The objective is to maximize the quality of the signal while minimizing burden and maintaining patient comfort. Sensor wear position impacts the accuracy and precision of digital clinical outcome measures.

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An Alternative to the 6MWT in Virtual Clinical Trials

Posted by Patrick Hankey on March 12, 2021

Digital innovation in clinical trial research has been accelerated because of the COVID-19 pandemic. Wherever possible, in-clinical assessments are being replaced with measures taken outside the study site. Decentralized trials present a new challenge to accurately capture data in real-world settings, such as the home or workplace. Here we illustrate how an outcome measure from a wearable sensor can be used as an alternative to the 6-Minute Walk Test (6MWT).

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Digital Health Technologies in Clinical Drug Development

Posted by Dudley Tabakin on February 16, 2021

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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Using Wearable Sensors to Assess Sleep-Related Outcome Measures

Posted by Kate Lyden on February 5, 2021

Sleep-related outcome measures obtained with wearable sensors provide valuable data in clinical trials. In addition to reducing the tremendous burden and cost associated with the traditional methods of assessing sleep, they offer an opportunity to take a more in-depth, day-to-day look into how a patient feels, functions, and survives.

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A Look into the Future of VivoSense V3 Endpoint Development

Posted by Kate Lyden on December 10, 2020

We really like validation: in fact, you might say we take it personally. It’s the foundation of everything we do. We are excited to report that we’re nearing the completion of a study that we believe will greatly expand the possibilities of digital outcome measures in clinical trials.

The research includes steps 1 and 2 of the V3 framework, verification and analytical validation. The outcome will be validated, machine learning algorithms to derive novel, real-world measures of physical function and mobility from wearable kinematic sensors (e.g., accelerometers, gyroscopes). Here’s an overview of our approach to the study and development efforts.

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Guide to the Shared Foundation for Digital Clinical Measurement

Posted by Dudley Tabakin on November 24, 2020

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.

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Biomarkers vs. Clinical Outcome Assessments (COA) vs. Endpoints

Posted by Kate Lyden on October 29, 2020

COAs, Biomarkers, and Endpoints, Oh My!

Establishing a common vocabulary accelerates progress by enabling effective communication and collaboration among stakeholders and facilitating cross-study comparisons and evidence harmonization. However, when we work with clinical researchers, they often use the words biomarkers, clinical outcome assessments (COA’s), and Endpoints interchangeably, but technically they mean different things.

I’m confident that my amazing team members often think I’m crazy when I deliberate or nitpick over the use of a single word. The point is words matter, especially in science and definitely in a new field like digital medicine. As this field evolves, definitions and key terms must be used consistently to reduce the hindrance of evaluating and interpreting scientific evidence.

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