Patient Considerations & Involvement

Patient preferences

DCTs may be less burdensome for participants than conventional trials, as travel to the research site is reduced or eliminated and trial visits can be carried out from the participant’s home or immediate vicinity by applying digital technologies and operational innovations. To tailor DCT elements to patients and lower the participation burden, we need to understand what the preferences are for participation in clinical trials with different levels of decentralisation.

Recommendations

We recommend clinical design teams to integrate patient preferences (and caregiver preferences in case of pediatric trials) for trial participation into the trial design. Teams should also take into account possible differences in preferences among people of, for example, different age or gender.

Our research showed that participation in clinical trials that are either fully decentralised or hybrid is preferred over participation in site-based clinical trials in individuals with type 2 diabetes mellitus in Germany, Austria and the Netherlands. We recommend clinical trial design teams to consider implementing decentralised trial elements in future trials, taking into account the specificities of the therapeutic area of the trial.

How Trials@Home reached these recommendations

To investigate what motivates people to participate in a clinical trial from home, we first conducted focus group discussions. We identified main drivers for trial participation, which provided a basis for the quantification of the importance of these drivers through a patient preference study. Preference data were obtained in a discrete choice experiment (DCE), which enabled us to gain insights into participation preferences and to estimate acceptance rates for different hypothetical trial scenarios. We were also able to identify differences in preferences among individuals and to determine which characteristics impact these preferences.

Further reading

Publications

What motivates people living with type 2 diabetes mellitus to participate in clinical trials from home? Findings from a multi-country focus group study on decentralised clinical trial approaches.
Kopanz, et al
Clinical and Translational Science
2024