Patient preferences on decentralised clinical trial approaches: insights from a focus group study with Diabetes Mellitus Type 2 patients to identify attributes
Principal Author: Julia Kopanz
Purpose: To identify the drivers (attributes) for participation in clinical trials with different decentralisation levels in persons living with type 2 diabetes mellitus (T2DM). Background Decentralised clinical trials move away from conventional in-person study-site-visits to the participant’s environment by using innovative digital technologies. Centering of trial activities around participants: Promises easier trial access & 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 decentralisation levels.
Approach
Step 1: Literature search was performed to identify attributes for clinical trial participation identified in the literature. Iterative discussion rounds with researchers were conducted to narrow down a total of 30 identified attributes condensed to nine attributes: Step 2: Next, various focus group sessions were held in the Netherlands, Austria and Germany to discuss new attributes, and rank the existing attributes from the literature research. Each group consisted of around 6 people with T2DM.
Conclusion: Focus groups are essential to identify relevant attributes. A transparent and predefined methodology is important. Drivers for participation in clinical trials are important, e.g. to design future patient-centric clinical trials and to increase participation in clinical trials. Next steps: finalize focus groups and elicitation of preferences within a discrete choice experiment based on attributes & levels identified in this study.
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