Stakeholder-reported perspectives on decentralized clinical trials: A multi-country descriptive survey

Decentralized clinical trials (DCTs), which enable trial activities to occur outside traditional clinical trial sites, are reshaping the landscape of clinical research by enabling patient-centric, flexible, and digitally supported trial models. However, widespread adoption faces regulatory, operational, and technological challenges. This study aimed to assess stakeholder perceptions, implementation trends, benefits, and challenges of DCTs across various settings. A cross-sectional, mixed-methods online survey using convenience and snowball recruitment was conducted among 288 stakeholders involved in clinical research, including sponsors, contract research organizations, hospitals/medical research institutions, and technology providers across 38 countries. Findings represent stakeholder-reported experiences rather than population-level adoption. This paper presents quantitative data analyzed using descriptive and exploratory bivariate analyses. Hybrid and full DCT implementation were reported by 144/164 (87.8%) and 63/164 (38.4%) respondents, respectively (independently-reported categories and not mutually exclusive). North America and Asia were the regions most frequently reported by respondents. The most commonly used DCT components were electronic patient-reported outcomes/electronic clinical outcomes assessments [117/161 (72.7%)], remote monitoring [114/161 (70.8%)], and electronic consent [96/161 (59.6%)]. Stakeholders identified key benefits, including improved patient convenience [152/228 (66.7%)] and real-time data collection [136/228 (59.6%)], while key barriers included patient technology literacy [127/228 (55.7%)] and site staff adaptation [123/228 (53.9%)]. Within this sample, hybrid DCTs were selected more frequently on model-effectiveness item; however, the findings do not establish general superiority of one model. Model suitability remains trial-context dependent. Addressing regulatory, infrastructural, and training-related challenges is critical for broader adoption. These findings document stakeholder-reported experience on DCT implementation approaches across diverse healthcare settings.