Do all individuals with type 2 diabetes mellitus prefer decentralisation in clinical trials? Findings from a discrete...

To explore differences in preferences for participation in trials with varying degrees of decentralisation among individuals with type 2 diabetes mellitus (T2DM) and to show how personal, disease specific, digital and trial experience factors influence these preferences as well as impact potential trial participation rates.

A discrete choice experiment was conducted, including 16 choice tasks, with each two trial options and an opt-out.

Preference data was collected in the Netherlands between July 2023 and July 2024.

A total of 276 individuals with T2DM aged ≥18 years took part in the study.

Trial options comprised six attributes: contact with the study team, activities to perform yourself, use of digital technologies, number of scheduled contacts, trial duration, safety and efficacy of the drug. Preference heterogeneity was explored using a latent class analysis.

Four classes were identified displaying differences in preferences for trial designs. Younger female participants were more likely to have a strong preference for decentralised trials in any form. Two different classes of elderly participants were identified: elderly males who were more likely to accept any trial design including decentralisation versus elderly who were more likely to be averse to participation in all trials. The latter class showed an increase in participation probability for a home-based trial including video consultation, but still was not very likely to join.

Decentralisation in trials was overall preferred over site-based trials, but variation in preferences was identified and associated with age and gender. This may impact the choice for decentralisation in trials, especially since women and the elderly are often under-represented in trials. Understanding patient preferences may help to overcome participation challenges and to increase diversity in future trials.