Exponent and DiMe Collaborate to Show the Value of Digital Endpoints

Adoption of digital health measurements in clinical trials promises to improve health outcomes and advance technological development

Exponent previously partnered with the Digital Medicine Society (DiMe) to expand the adoption of its V3 framework for evaluating digital health technology (DHT) reliability. Now Exponent is partnering with DiMe again to accelerate the adoption of digital technologies in clinical trials by demonstrating their potential benefits.

Exponent experts are leveraging their extensive background in digital health technology, research methods, data collection, and mechanical engineering in collaboration with DiMe's Digital Health Measurement Collaborative Community (DATAcc) to establish industry benchmarks for evaluating the return on investment of digital endpoints in the development of medical devices, drugs, and other regulated interventions. By contributing our technical knowledge of device attributes and usability, computation of sensor data into reliable endpoints, and study design and evidence generation to quantifying the value of digital endpoints, our team is helping stakeholders improve clinical research and reduce costs and timelines for clinical trials by enhancing and deploying new technologies.

Exponent's experts include electrical engineers, human factors specialists, data scientists, clinical researchers, epidemiologists, and statisticians. Our truly interdisciplinary approach allows contributions to this initiative that span the lifecycle of digital endpoint development — from conceptualization, device selection and adaptation to computation of measurements, final validation, and implementation.

Why digital data?

Using digital endpoints has the potential to reduce the size and cost of clinical trials compared to conventional data collection methods. Because digital measurements can be collected more quickly and frequently, they can provide more efficient and more detailed evidence for the effect of therapeutics (including drugs, biologics, and devices). Including digital measurements in clinical trials may substantially increase information on the benefits and risks of a product, improve patient-centeredness, and shorten time to approval.

These benefits can accrue through various mechanisms, for example:

• Increasing the frequency and granularity of information collected on key endpoints
• Reducing the number of participants needed in clinical trials 
• Reducing the cost of endpoint measurement per participant
• Improving access to products by measuring endpoints of specific relevance to payers

Establishing industry best practices

According to DiMe, the goals of the project are to "establish shared industry benchmarks for evaluating the return on investment in digital endpoints in the development of drugs, medical devices, and other regulated interventions and support organizations developing the business case for digital endpoints to advance the development, implementation, and scale of fit-for-purpose digital measures as endpoints in clinical trials."

DiMe describes two workstreams for achieving project goals:

1. Defining the value framework associated with the use of digital endpoints by assessing the factors used to decide whether to use a digital tool for capturing trial endpoints in a study protocol 
2. Developing a business model that innovators and leaders can pull from to articulate the value of digital endpoints based on the value drivers that best align with their portfolio and organizational priorities.

The project is expected to be completed by Q1 2025.