Science Blog

Digital Biomarkers

The Value of Exploratory Endpoints in Early Phase Trials

Posted by Kate Lyden on October 5, 2021

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More
 Newer All Articles Older 

Subscribe to Email Updates

Stay Connected

Popular