More Digital, More Diverse? How Digital Health Technologies Contribute to Representativeness of Clinical Trials

The rapid adoption of digital health technologies (DHT) in clinical trials promises to enhance trial representativeness by eliminating geographical barriers and reducing participant burden. However, their actual impact on participant representation remains poorly understood. Our analysis of 68,206 US-based trials from ClinicalTrials.gov uncovers gaps in participant representation in trials utilizing DHT for data collection (DHTcd). While DHTcd trials achieved overrepresentation of female participants (+1.7% versus US Census data and +5.5% vs. non-DHT trials) and reduced underrepresentation of Black participants by 4.2% (vs. non-DHT trials), they showed underrepresentation of adults aged 65 years and older (-8.8% vs. non-DHT trials). These effects vary by therapeutic area. We furthermore find that DHTcd trials report group-specific sample compositions less frequently than non-DHT trials, suggesting that growing DHTcd adoption has not been systematically used to improve trial representativeness. We conclude that evidence-based and indication-specific implementation strategies are needed to enhance standards for DHT-based data collection in clinical trials and to prevent a widening digital divide in trial participation.