Digital measures provide unprecedented insights into patients’ symptoms and experiences. By reducing trial costs, improving efficiency, and enhancing outcomes, digital endpoints have the potential to transform clinical research. While digital endpoints have demonstrated substantial potential for generating financial benefits, securing stakeholder buy-in and investment remains challenging without a standardized framework to measure impact and return on investment (ROI).
DATAcc by DiMe has developed resources to help you build a compelling business case for adopting digital endpoints in clinical trials. These resources highlight the value, drivers, demonstrate potential ROI, and equip you with the data needed to unlock the full potential of digital endpoints to improve patient outcomes and the drug development process.
Digital Endpoint
A precisely defined variable intended to reflect an outcome of interest that is 1) collected digitally with a sensor, and 2) statistically analyzed to address a particular research question.
Who will benefit from these resources?
Pharma & Biotech
DHT developers
Digital Endpoints Value Framework
The first step in your journey to leveraging digital endpoints is identifying their value across different trial phases. This value framework highlights the expected benefits at each stage and the conditions required to realize their advantages.
Value of Digital Endpoints: Case Study Catalog
The case study catalog reinforces the value framework with real-world examples from eight organizations, demonstrating the impact of digital endpoints with measurable benefits like cost savings and improved outcomes—inspiring you to strengthen your business case.
Digital Endpoints ROI Calculator
Building on the value framework, the ROI calculator quantifies the potential ROI of incorporating a digital endpoint in your trial. Use it to demonstrate the financial benefits and build a strong, data-driven case for stakeholder buy-in.
Digital Endpoints Business Case Template
Build a compelling business case for digital endpoints by clearly communicating their value and ROI through a strategic, data-driven proposal that aligns with organizational goals and maximizes impact.
Discover how others are using these resources
“As the field of DHT-enabled measures continues to mature, it was very illuminating and reassuring to hear from the biopharmaceutical industry, the technology sector, and academia about progress made in the field since the inception of DiMe and the publication of the V3 framework, which were fundamental to the field. We have heard each other’s stories, shared experiences, and developed resources that will help us move forward together and faster.”
“The ROI calculator will have a significant impact across multiple areas. It will help tech developers create digital endpoints that meet economic and clinical needs, improving marketability. Researchers and institutions can use it to justify funding by demonstrating cost-effective, data-backed outcomes. It will be particularly valuable in Phase 2 and Phase 4 trials, where digital endpoints are widely used, providing more data. Healthcare payors and insurers may leverage it to assess long-term cost savings and treatment benefits, potentially influencing coverage decisions and reimbursement strategies. Additionally, it offers investors a clear financial rationale for funding companies developing or utilizing digital endpoints, attracting more capital to the space.”
“Digital endpoints must provide a clear return on investment so they may progress from the research and development realm and deliver on the promise of these technologies and measures. The resources developed in this project will provide decision-makers with tools and confidence to evaluate the value of using digital health technology in a registrational clinical trial.”
“DiMe’s Business Case project provides the digital health technology ecosystem with standard language to articulate the value of digital endpoints. With the output from this project, we look forward to seeing accelerated adoption of digital endpoints across the industry.”
“DiMe’s Business Case project offers a comprehensive overview of the value of digital endpoints in clinical trials and beyond. Utilizing the value framework and ROI calculator equips users with practical tools to assess the value for specific use cases. This enables TNO to focus their digital endpoint development on applications that yield the greatest impact.”
“Verily has invested in an ecosystem to improve research and patient care, distinguished by our data and AI expertise. By leveraging DiMe’s collaborative platforms and resources, which provide a forum for aligning with regulatory bodies, clinical experts, and other industry leaders, we’ve accelerated innovation and implemented more precise, data-driven solutions. DiMe has been key in advancing our understanding of digital endpoints, helping us build a more robust and reliable path forward.”
Martha O’Neill, Health Advances, outlined the Digital Endpoints ROI Calculator methodology, highlighting its flexibility in assessing financial impact, demonstrating value, and testing scenarios.
Martha O’Neill, Health Advances, explains how the calculator fosters cross-organization discussions on digital endpoint benefits, with future data enabling even greater impact quantification.
Jeff Abraham, Health Advances, shares how the Digital Endpoints ROI Calculator simplifies quantifying digital endpoints and will evolve yearly to stay industry-aligned.
Joseph DiMasi, Tufts Center for the Study of Drug Development, highlights how the Digital Endpoints ROI Calculator will expand to new therapeutic areas and improve with more data over time.
Libby Floden, Eninova, discusses how these resources enhance efficiency, align strategies, and deliver both financial and patient benefits.
Marissa Dockendorf, Merck, highlighted the power of collaboration in this project, emphasizing how bringing together stakeholders from different companies fostered knowledge-sharing and led to the development of these valuable tools.
More about this project
The global mental health crisis needs bold solutions, and DATAcc is leading the way. Our upcoming project will create a core digital measure set for common mental health disorders, building on our recent research commissioned by Wellcome to redefine mental health care for researchers, clinicians, regulators, patients, and payors.