OBJECTIVES: Innovations in clinical trials, such as decentralized clinical trials (DCTs), promise to overcome some of the challenges faced by conventional clinical trials, e.g. regarding recruitment, diversity, retention and participant burden. In DCTs, this could be achieved by moving trial activities to the participants’ direct surroundings by using digital innovations and other innovative operational approaches. However, there is no evidence available on what potential trial participants prefer regarding trial designs. Therefore, our aim was to determine the preferences and trade-offs for participation in clinical trials with different decentralization levels in persons with type 2 diabetes mellitus.

METHODS: A discrete choice experiment (DCE) was conducted in the Netherlands, Germany and Austria. Participants were asked to complete a survey with 16 DCE choice tasks and background questions concerning characteristics. Each choice task comprised of three options: two trial options described by six attributes and an opt-out option. Panel Mixed Multinominal Logit models were used in the interim data analyses.

RESULTS: Interim results on the Dutch population (n=210) showed that they a priori preferred to participate in a trial over opting out. All attributes significantly contributed to their choices, the ‘safety and efficacy of the drug’ (Mean±SD: -2.13±2.00) being the most important, followed by ‘where and how you are in contact with the study team’ (-1.20±1.16) and ‘number of scheduled contact times’ (0.93±0.33). Significant preference heterogeneity was observed for all included attributes except for ‘use of digital technologies’.

CONCLUSIONS: Our interim findings suggest that taking into account the contact with the study team and the number of scheduled contacts in the design may influence whether people are willing to participate. Understanding the preferences for trial participation from home is important for the future of clinical trials. Further research may be needed to determine the preferences regarding trial participation in other therapeutic areas.