COPD Foundation partners with Digital Medicine Society to advance the use of digital health measures in clinical research
FDA has qualified the first digital endpoint for clinical trials
MIAMI (June 18, 2024) - The COPD Foundation is collaborating with the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) on a new project aimed at increasing the use of digital endpoints in clinical trials.
In health care and clinical research, an endpoint is an outcome used to assess the effectiveness of a treatment or intervention. It is a specific measure that a study aims to investigate, helping to determine if a treatment is effective and safe and guiding clinical and regulatory decisions.
Digital endpoints are health outcomes collected outside of a clinic using wearable sensors, mobile apps and other digital health technologies. They are used in patient care and clinical trials to provide a complete health assessment with real-time data in a person's own environment. Examples of digital endpoints include sleep quality, steps per day and heart rate.
Under the Medical Device Development Tools (MDDT) program, the FDA has qualified the first digital endpoint for clinical trials, exemplifying the growing adoption of digital health measures. This is a long-awaited big win for digital clinical measures in clinical trials - it will revolutionize how outcomes are measured, enhancing accuracy and efficiency in research.
The COPD Foundation is a partner on the DATAcc by DiMe's "Building the Business Case for Digital Endpoints" project, which is working to develop ways to measure the value and effectiveness of using digital endpoints. Implementing digital endpoints benefits people with chronic obstructive pulmonary disease (COPD) by continuously monitoring their condition, providing data on exacerbations (flare-ups) and other symptoms over time. Mobile technology enables more people, including those in rural areas, to participate in clinical research. COPD affects more than 30 million Americans, and approximately two million of those are in rural locations.
"Expanding the use of digital endpoints in clinical research will benefit COPD patients and clinical research on chronic lung disease," said Jean Wright, M.D., MBA, CEO of the COPD Foundation. "Digital measures provide the clinical trials community with insights into people's lives and advance our understanding of symptoms and other health indicators. We are proud to partner with DiMe to develop resources and processes that improve the ways we incorporate digital health into research and patient care."
DATAcc is developing a framework and resources to measure and evaluate the ROI generated by digital endpoints used in clinical trials, aiming to help organizations build a compelling case for continued investment in digital strategies.
"Digital measures bring immense value to clinical research, reducing costs and speeding new drugs and therapies to market," said Victoria Bangieva, PhD, Program Director at DiMe. "We're excited to partner with the COPD Foundation on this important work to develop resources that will advance the use of digital health measures in research to improve lives."
DATAcc is a collaborative community with the Federal Drug Administration's Center for Devices and Radiological Health. The program brings together leaders from across government, pharma, policy organizations, nonprofits and the private sector to approach complex medical device challenges from an interdisciplinary perspective.
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About the COPD Foundation
The COPD Foundation is a nonprofit organization whose mission is to help millions of people live longer and healthier lives by advancing research, advocacy, and awareness to stop COPD, bronchiectasis, and NTM lung disease. The Foundation does this through scientific research, education, advocacy, and awareness to prevent disease, slow progression, and find a cure. For more information, visit copdfoundation.org, or follow us on Twitter and LinkedIn.
Contact:
Brittany Irish
805-465-2497
mediarelations@copdfoundation.org