Blog | 7/22/2025

From Pilot to Protocol: Digital Measures Take Hold

Digital measures—objective, quantifiable physiological and behavioral data collected through digital devices—are still largely in exploratory use. Only~ 20% of trials currently incorporate digital measures, with projections rising to 25–30% by 2030. Adoption varies widely across therapeutic areas and trial phases: neurology leads at 40%, followed by dermatology and metabolic disorders. Use is most prominent in Phase IV, where broader health outcomes are examined, and least common in Phase I, though early-stage oncology and respiratory trials are beginning to incorporate wearables for sleep and cardiac metrics.

Despite growing enthusiasm, adoption remains cautious. Sponsors often rely on vendor platforms with minimal customization, constrained by compressed timelines and limited capacity to develop and validate novel digital measures in-house. Regulatory ambiguity continues to hold them back, as many are reluctant to pursue labeling claims without clearer frameworks for evaluating digital endpoints. Even when data is collected, its clinical relevance can be difficult to establish, and the urgency to accelerate trial timelines in biotech often sidelines the time-intensive work of endpoint development.

Over the next five years, that could change. Advances in AI and multi-omics, combined with increasing regulatory clarity, are poised to shift digital biomarkers from experimental tools to integral components of trial design and drug development.

To help quantify the value of digital measures, Health Advances partnered with the Digital Medicine Society (DiMe) to develop a dynamic ROI calculator. This tool models how digital measures can reduce trial costs, shorten timelines, and improve the probability of regulatory success.