{"id":41868,"date":"2026-03-19T10:12:54","date_gmt":"2026-03-19T09:12:54","guid":{"rendered":"https:\/\/www.cosinuss.com\/?p=41868"},"modified":"2026-03-19T10:13:43","modified_gmt":"2026-03-19T09:13:43","slug":"digital-endpoints-in-clinical-trials-building-the-business-case-for-systematic-adoption","status":"publish","type":"post","link":"https:\/\/www.cosinuss.com\/en\/2026\/03\/19\/digital-endpoints-in-clinical-trials-building-the-business-case-for-systematic-adoption\/","title":{"rendered":"Digital endpoints in clinical trials: building the business case for systematic adoption"},"content":{"rendered":"

New article published in \u201cNature Reviews Drug Discovery\u201d<\/h2><\/div>

In June 2024, DiME launched the DATAcc project \u201cBuilding the Business Case for Digital Endpoints,\u201d to which cosinuss\u00b0 made a valuable contribution as a partner, leveraging its extensive expertise in the measurement of vital signs (see press release<\/a>). The project team has now published an article in the journal \u201cNature Reviews Drug Discovery\u201d on the operational and financial benefits of digital endpoints throughout the entire clinical trial pipeline. We at cosinuss\u00b0 are proud to be part of this project and to have had the opportunity to contribute to the publication.<\/p>\n<\/div>

Investments in digital endpoints present a major opportunity<\/h2><\/div>

Digital endpoints have been shown to provide high-quality, objective data that better reflects patients\u2019 functional status and well-being. DiME\u2019s work now makes it clear that insufficient investment in the integration of digital endpoints into clinical trials represents a huge missed opportunity. The work of this collaborative group found that an investment of a median of $1 million to implement a digital endpoint in a clinical trial paid off significantly. For example, in a Phase III trial, the return was 13.9 to 21.9 times the investment, while simultaneously shortening the trial duration by 4 to 5 months and reducing the number of participants by 12%. The analysis of 164 studies thus shows that digital endpoints – particularly in cardiovascular, CNS, and diabetes studies – lead to shorter study durations, smaller participant numbers, and faster decisions.<\/p>\n

These results demonstrate measurable, repeatable, and scalable added value. Digital endpoints are already delivering operational efficiency gains and financial returns in ongoing programs, or are expected to do so.<\/p>\n<\/div>

Tools to quantify ROI and accelerate digital endpoint adoption<\/h2><\/div>

In addition to the publication, the project group also developed an ROI calculator for digital endpoints that can be used to estimate the ROI for a specific study based on industry benchmarks. To foster collaboration across traditionally siloed organizations and departments, the sDHT Adoption Navigator was also introduced – a free, open-access platform featuring more than 300 vetted regulatory documents, scientific standards, and industry best practices, organized around real-world decision points. NaVi is a personal AI research assistant that can help teams collaboratively build a comprehensive business case.<\/p>\n

We are excited to continue being part of this project to further advance the adoption of digital health measures in clinical trials.<\/p>\n<\/div>

More information and resources<\/h3><\/div>