OBJECTIVES: Decentralized clinical trials (DCTs) move away from conventional in-person study-site-visits to the participant’s environment by using innovative digital technologies. This centering of trial activities around participants promises easier trial access and less burden for participants, but will also result in less face-to-face contact with health-care-professionals. Little is known about the drivers for participation in clinical trials with different decentralization levels. The aim of this focus group study was to identify these drivers (attributes) of participation for persons with type-2-diabetes (T2D). The findings will be used to elicit preferences in a discrete-choice-experiment (DCE).

METHODS: Attributes identified from literature were narrowed down in iterative discussion sessions by researchers by removing duplicates and interacting attributes and by grouping similar attributes. Focus group sessions were held in two European countries with persons with T2D (4-6 participants per group) using the nominal group technique to prioritize attributes for the DCE. Participants first generated their own ideas which were subsequently discussed, complemented with attributes from literature and compounded to a final set. Finally participants were asked to individually rank the attributes from most important to least important and an overall ranking score was estimated.

RESULTS: A total of 30 attributes identified from literature were condensed to nine attributes by researchers. Through several focus group sessions attributes were further defined, discussed, and sharpened to a final set for DCE use. Some of the attributes identified were the location of trial activities, travel time per visit, data collection, risk and safety of the investigational medicinal product.

CONCLUSIONS: Focus group sessions are essential in defining relevant attributes. A transparent process is warranted to arrive at those that are most meaningful and relevant. Further elicitation of preferences within a DCE is an important next step to understand patient preferences and drivers of participation in DCTs.