ScholarWorks@성균관대학교

초록

Objectives To examine the association between decentralised clinical trial (DCT) adoption and trial duration in metabolic disease trials. Design Retrospective cross-sectional analysis using analyst-curated metadata from the GlobalData Clinical Trials Database, matched with ClinicalTrials.gov records via unique identifiers. Setting Industry-initiated phases 1-3 trials for metabolic diseases involving the USA (first patient enrolment 2015-2023). Participants 444 trials (phase 1: n=140; phase 2: n=155; phase 3: n=149). Main outcome measures The primary outcome was clinical trial duration (CTD), defined as the interval from first patient in (FPI) to last patient last visit. The secondary outcome was the primary completion period (PCD-FPI), used for sensitivity analysis. Results Among 444 trials, 124 (27.9%) were identified as DCTs. Adoption differed significantly across clinical phases (phase 1: 11.4%; phase 2: 29.7%; phase 3: 41.6%; p < 0.001). Two-way analysis of variance showed that clinical phase was significantly associated with CTD (F = 27.4, p < 0.001), whereas the main effect of DCT adoption was not significant (F = 0.202, p = 0.653). Phase 2 and 3 DCTs exhibited numerically shorter mean durations (17.3 vs 18.3 months; 23.4 vs 25.0 months), but these differences did not reach statistical significance (p > 0.05). In phase-stratified regression analyses, DCT status remained non-significant across all phases. Older adult inclusion was associated with shorter CTD in phase 3 (beta = -0.39, p < 0.001). Sensitivity analysis using PCD-FPI yielded consistent findings. Conclusions DCT adoption was not significantly associated with shorter trial duration in metabolic disease trials after adjustment for clinical phase and clinical characteristics. These findings may reflect the current stage of DCT implementation, in which operational complexities may coexist with theoretical expectations of efficiency. Further evaluation in more mature implementation settings may clarify whether decentralised approaches are associated with improved efficiency.

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