SCOPE Summit 2026: Advancing Digital Endpoints Through Performance and Regulatory Alignment

In a recent video interview with Applied Clinical Trials at the 2026 SCOPE Summit, Jeremy Wyatt, CEO, Ametris, outlined the operational realities of integrating digital endpoints and wearables into clinical trials, with a particular focus on oncology. Wyatt emphasized that successful adoption hinged on reducing patient burden through thoughtful workflow design, careful device selection, and robust global logistics. He explained how continuous, real-world digital measures improved sensitivity, enhanced patient centricity, and increased trial efficiency, while also enabling fewer clinic visits and, in some cases, smaller sample sizes. Wyatt also stressed the importance of early and ongoing collaboration with regulators to support co-development, reduce adoption risk, and establish consistent validation standards that allowed digital endpoints to scale across programs. Clear communication with sites and patients, he noted, was essential to driving adherence and maximizing the value of these technologies.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

How can the use of digital endpoints enhance any given clinical trial?

Wyatt: I get this question a lot, and we strongly believe that nearly every trial can benefit from a digital measure. One reason is sensitivity. Digital measures allow for continuous data collection in a patient’s real-world environment, rather than episodic measurements taken during site visits.

Another key benefit is patient centricity. These measures reflect what matters to patients in their daily lives—how they move, function, and feel outside of a controlled clinical setting. That real-world relevance is incredibly powerful.

Efficiency is also a major advantage. Digital measures enable continuous engagement with patients while often reducing clinic visits and overall burden. In some cases, we’ve even seen reductions in required sample size due to the statistical power of these measures. In one Phase III pivotal study, the use of digital measures enabled a 50% reduction in the required patient population because of that increased sensitivity.

Can you explain the importance of collaborating with regulators in advancing the use of digital endpoints?

Wyatt: Regulatory engagement is absolutely critical. We focus on alignment not only with sponsors, but also with regulators and health authorities, including the FDA, EMA, and others globally.

First, digital endpoints are viewed as a co-development effort. Regulators are actively working with industry to help shape standards, and engaging early reduces surprises later in the process.

Second, early regulatory involvement builds confidence—among patients, sites, investigators, and sponsors. When everyone is aligned, adoption risk is reduced.

Finally, consistency matters. Clear regulatory expectations around validation and evidence generation allow digital endpoints to be repeatable and acceptable across multiple programs, not just one study. That consistency is essential if we want to scale digital measures across clinical development.