A new project aimed at increasing the use of digital endpoints in clinical trials is being spearheaded by the COPD Foundation in collaboration with the Digital Medicine Society.

RT’s Three Key Takeaways

  1. The COPD Foundation is partnering with the Digital Medicine Society (DiMe) to promote the use of digital endpoints in clinical trials through a project aimed at measuring the value and effectiveness of these digital health measures.
  2. Digital endpoints, such as sleep quality and heart rate, are collected using wearable sensors and mobile apps, providing real-time health data outside clinical settings, and the FDA has qualified the first digital endpoint for clinical trials under the Medical Device Development Tools (MDDT) program.
  3. This collaboration will benefit COPD patients by continuously monitoring their condition and enabling participation in clinical research, especially for those in rural areas, thus enhancing accuracy and efficiency in clinical trials.

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 healthcare 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 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, MD, 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.