DATAcc by DiMe Releases Resources to Build the Business Case for Digital Endpoints

New tools will calculate the ROI of using digital endpoints in clinical trials, empowering greater innovation in research

BOSTON, March 26, 2025 /PRNewswire/ -- Today, the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe), the global home for digital health measures development, released a suite of resources designed to help clinical trial sponsors and digital health technology (DHT) developers effectively demonstrate the value of using digital endpoints in clinical trials.

Last year, research found significant cost reductions and financial benefits tied to using digital endpoints in clinical trials, for both large pharma as well as smaller biotechs. For instance, the findings indicate that digital endpoints can reduce costs of Phase 3 studies by up to $48 million, yielding a four to seven times return on investment. 

Despite these benefits, digital health experts often face challenges advocating for digital endpoints, gaining leadership buy-in, and demonstrating their value to potential partners. Securing investment and support for expanding digital endpoint strategies is difficult without a standardized way to assess their impact and demonstrate clear ROI data, which has been nearly impossible – until now.

DATAcc's new resources guide stakeholders in leveraging data to make the business case for greater adoption of digital endpoints in clinical trials:

• The Digital Endpoints Value Framework outlines the value drivers of digital endpoints in different trial phases and helps you navigate their roles across different stages of development.
• The Digital Endpoints ROI Calculator supports pharmaceutical, biotechnology, and digital health technology stakeholders in making data-informed decisions about using digital endpoints. It also helps articulate the measurable benefits, convince key decision-makers, and provide concrete data.
• The Digital Endpoints Business Case Template offers a well-organized approach to aligning a business case with portfolio goals and organizational priorities, ensuring decisions for digital endpoints are strategic and data-driven.
• The Case Study Catalog offers real-world examples from 8 organizations that used digital endpoints to deliver measurable benefits in clinical trials.

"Digital measures provide untapped opportunities and insights into people's symptoms and experiences, advancing our understanding of many diseases," said Elena Izmailova, Chief Scientific Officer, Koneksa. "Leveraging digital endpoints will help us advance trials that are more patient-centric and supported by ecologically valid data. It's incredibly valuable to have these new resources to articulate the business case for adopting digital endpoints and highlight their potential to enable novel study designs, get high quality data, and enable decision making."

"Leveraging new technology and more data to reduce costs and improve patient outcomes shouldn't be an uphill battle," added Victoria Bangieva, Program Director, DiMe. "But feedback from colleagues across pharma and health tech revealed the struggles they face in expanding their use of digital endpoints. Our new tools will remove that barrier and make it easier to advance digital endpoints by proving their value to organizations, to patients, and to healthcare overall."

DATAcc is actively tackling some of the most pressing challenges in digital medicine. Industry leaders are invited to collaborate on ongoing initiatives, such as the development of a core digital measure set for common mental health disorders. This project builds on DiMe's latest research commissioned by Wellcome and aims to define digital measures that benefit researchers, clinicians, regulators, patients, and payers. To learn more and participate in these pioneering efforts, click here and join the movement to shape the future of digital medicine.

About the Digital Medicine Society: DiMe is a global non-profit and the professional home for all members of the digital medicine community. Together, we tackle the toughest digital medicine challenges, develop clinical-quality resources on a technology timeline, and deliver these actionable resources to the field via open-source channels and educational programs.

About DATAcc by DiMe: The Digital Health Measurement Collaborative Community (DATAcc) by DiMe is a collaborative community with the FDA's Center for Devices and Radiological Health. We 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.

Media Contact: Carla English, [email protected]

SOURCE Digital Medicine Society (DiMe)