Julia Kopanz

Patients at the centre: Unravelling perspectives on decentralisation of clinical trials

Samenvatting

Decentralised clinical trials (DCTs) allow patients to participate in trials from home or their immediate surroundings. This shift in trial location promises many advantages, yet how participation in DCTs is viewed and experienced remains unclear. This was investigated in this thesis, as well as how certain trial elements, specifically physical examination (PE), can be decentralised. The results showed that, in people living with type 2 diabetes mellitus, motivations for trial participation varied and that patients had a higher willingness to participate in DCTs than in a traditional site-based trial. Challenges with technologies led to lower overall satisfaction with trial participation in a hybrid arm than in a conventional arm, but other trial elements had equally high satisfaction in both arms. PE was frequently mentioned in trial protocols but reasons for PE were poorly documented, and opinions on possible remote assessments differed among stakeholders. The findings of this thesis support that, depending on specific patients’ needs, decentralisation of clinical trials should be considered for future trials.