Munich/Boston (MA), June 6, 2024 – Digital measures provide clinical trials with unprecedented insights into patients’ real experiences and enhance understanding of various conditions. Recent findings1 show significant cost reductions and financial benefits from using digital endpoints in trials. DATAcc by DiMe launches its new project, “Building the Business Case for Digital Endpoints,” aimed at advancing the adoption of digital health measures in clinical trials. This initiative is set to boost investment in digital measurement by providing comprehensive tools and frameworks to demonstrate the value of digital endpoints. cosinuss° has joined the project team, to make a valuable contribution with our deep expertise in mobile or remote vital parameter measurements.

Innovative patient monitoring technology to collect valuable health data

cosinuss° is contributing its knowledge and expertise in advanced mobile patient monitoring and existing technology to the project. Our core is creating valuable, structured health data with a mobile solution ideal for decentralized studies, enabling patient monitoring from home. We want to provide solutions to seamlessly record, structure and oversee large amounts of qualitative vital data. With the in-ear sensor c-med° alpha and the Health° software, the most important vital parameters and quality values can be measured and evaluated continuously – remotely or on site. Several studies and projects already show that cosinuss° provides high-quality data (e.g. TeleCovid, CO-SI-ONKO). We are proud to support DiME’s goal of creating the business use case for digital endpoints in clinical trials.

Boosting the adoption of digital endpoints in clinical trials

Despite their proven cost savings and financial benefits, adoption of digital endpoints has been slow due to unclear value and deployment strategies. DATAcc’s project aims to overcome these challenges by developing resources to help organizations make informed decisions and sustain investments in digital health strategies. The project will establish a value framework, industry benchmarking tools, ROI forecasting models, support organizations in building the business case for digital endpoints in clinical trials, and help organizations optimize financial and operational strategies. “Digital measures can bring significant benefits to clinical research – improving the patient experience, saving costs, and speeding the path to uncover new cures to the issues facing patients today,” said Victoria Bangieva, PhD, Program Director, DiMe. “Despite these benefits and the speed of technology improvement, we see barriers to full acceptance. We’re excited to work with cosinuss° to create a set of open source resources to build a business case for greater use of digital endpoints, to advance research and improve the lives of patients.”

About DATAcc
The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) is a collaborative community with the FDA’s Center for Devices and Radiological Health. They provide a forum for collaboration where partners and experts from across the digital health field work to advance the use of digital health measures in research to improve lives.

About cosinuss°
Cosinuss GmbH is a certified medical device manufacturer based in Munich that specializes in mobile and continuous monitoring of various vital signs. With more than 15 years of research and development, numerous patents and medically certified products, cosinuss° is a pioneer and hidden champion in the field of mobile and continuous vital signs monitoring. cosinuss° follows the vision of revolutionizing the monitoring and recording of vital signs in various fields of healthcare.