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

Abstract 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. Competing Interest Statement The authors have declared no competing interest. Funding Statement This study did not receive any funding. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: N/A I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data produced in the present study are available upon reasonable request to the authors.