Science Blog

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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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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Developing Digital Biomarkers Post Covid-19

Posted by Dudley Tabakin on July 9, 2020

The 3rd Annual Digital Biomarkers in Clinical Trials Summit hosted by Roche was the virtual place to be in June, bringing together 250+ global thought leaders and experts. They shared insights on developing and improving the way pharma clinical trials utilize mobile-enabled, wearables, and IoT capabilities to augment existing biomarker strategies, improve patient experience, and collect better data.

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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’s an infographic highlighting the advantages using wearable technologies in your clinical trials.

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