Science Blog

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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VivoSense Awarded NIH/NCI Grant to Aid in Cancer Research

Posted by Dudley Tabakin on October 15, 2020

VivoSense, Inc. is proud to announce that we have been awarded an NIH/NCI Phase 1 contract to develop software enabling data integration from wearable sensors for cancer patients. The contract will result in the development of the VivoSense Cancer Health Informatics Platform as the leading wearable sensor agnostic cloud platform for cancer research and clinical care.

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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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New Release: VivoSense® Software 3.5 for Wearable Sensor Data Analysis

Posted by Dudley Tabakin on August 20, 2020

As the leading provider of visualization and analysis software for data from wearable sensors, we are committed to continually improving VivoSense and expanding its capabilities for our academic research partners. Here are some of the highlights of our recent release of VivoSense® 3.5.

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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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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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