Strados Labs is excited to announce its participation in a groundbreaking project led by the Digital Medicine Society (DiMe), a global non-profit dedicated to driving scientific progress and broad acceptance in digital medicine.

The project, Building the Business Case for Digital Endpoints is focused on advancing the use of digital endpoints, such as cough, wheeze and crackles, in clinical trials. While digital endpoints offer unprecedented insight into patients’ lived experiences, they have not yet become a central aspect of drug development and clinical trials. This project aims to highlight the value and ROI of using digital endpoints with goal of accelerating their use.

More about the project

  • 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. 
  • DATAcc’s top priority is advancing digital measurement and diagnostics because digital health measurement promises to improve lives for everyone. Through our robust portfolio, we’ve developed the digital clinical measures needed to improve health outcomes, economics, and equity—but how can we ensure the widespread adoption of these digital measures in the field? 
  • DATAcc by DiMe’s new project, “Building the Business Case for Digital Endpoints,” will increase investment in digital measurement development and deployment in clinical trials by developing a value framework, industry benchmarking tools, ROI forecasting models, and a modular template business case framework to support innovators across the field to invest in digital endpoints and advance their broad adoption and scale in clinical research.
  • The project will bolster the investment and use of digital endpoints by developing resources that provide decision-makers with concrete data, enabling them to clearly define the value of incorporating these business strategies. 

Why this matters 

  • Digital measures provide the clinical trials community with unprecedented insights into people’s lived experiences and advance our comprehension of many indications. By leveraging digital endpoints, clinical trials can be more patient-centric, data-driven, and adaptable to meet the evolving needs of healthcare research.
  • Based on DiMe’s partnership with the Tufts Center for the Study of Drug Development and industry leaders at Johnson & Johnson, Roche, Genentech, UCB, Bayer, Takeda, and MindMed, we now have strong evidence that demonstrates a substantial ROI when digital endpoints are used in clinical trials.
    • Our research produced fascinating data, with the findings showcasing evidence of significant cost reductions and financial benefits tied to leveraging digital endpoints in trials. 
    • What was a key takeaway from our research? We must continue to advance the use of digital endpoints to speed medical product development. 
  • While there is an increase in exploring various digital endpoints, they have not yet become a central aspect of medical product development. They lack clear value, routine use, and efficient strategies for deployment, hindering various benefits, like speeding up clinical trials and reducing costs.
    • Digital health experts encounter obstacles in gaining leadership support, integrating digital measures in clinical trials, and demonstrating the value of digital capabilities to partners involved in clinical development programs and trial planning.
    • Despite evidence of the financial benefits of digital endpoints, securing ongoing investment and backing for expanding digital endpoint strategies is challenging without a standardized value framework and conclusive ROI data in the current market landscape.
  • To address this, DATAcc is developing a framework and resources to measure and evaluate the ROI generated by digital endpoints, aiming to help organizations build a compelling case for continued investment in digital strategies aligning with their business goals and industry standards.
  • Our project will build the business case for digital endpoints so organizations can make informed decisions and sustain investment in integrating them into digital health strategies. Only then can we unlock the resulting benefits: improved patient care and operational efficiency. 

How this project will support the field

  • To improve patient care and operational efficiency with digital endpoints, this project will:
    • Establish shared industry benchmarks for assessing the ROI of digital endpoints in drug development, medical device innovation, and other regulated interventions.
    • Support organizations in building the business case for digital endpoints to facilitate the advancement, implementation, and widespread adoption of fit-for-purpose digital measures as endpoints in clinical trials.
    • Help organizations make informed decisions and sustain investment in integrating digital endpoints into digital health strategies.
  • By using these resources, organizations will learn how to optimize their financial and operational strategies by incorporating digital endpoints while accelerating clinical trial timelines. This dual approach will drive cost efficiency, expedite market entry, and foster quicker revenue generation by bringing products to market faster. 
  • These resources will empower digital health innovators who must make a compelling business case for developing and implementing digital measures.