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

Abstract

Decentralised clinical trials (DCTs) shift trial activities either entirely, that is a fully DCT, or partially, that is a hybrid trial, from the traditional research site to the participant’s home or local environment. DCTs promise to improve trial conduct and reduce burden, yet it is unclear what patients’ perspectives on DCTs are. This thesis investigated patients’ perceptions, preferences and satisfaction regarding participation in DCTs and explored the opportunities for decentralising certain trial elements, using physical examination (PE) as an example. Focus groups revealed that people living with type 2 diabetes mellitus had different motivations for trial participation and that flexibility of location and time investment were the most important drivers for DCT participation. Quantitative analysis showed that patients had a higher willingness to participate in fully decentralised and hybrid trial scenarios compared to a site-based trial. When investigating satisfaction with trial participation in a clinical trial with different levels of decentralisation per arm, overall satisfaction declined over time in the hybrid arm due to technological difficulties, but remained constant in the conventional arm. However, satisfaction was found to be equally high in both arms for other components. An assessment of clinical trial protocols showed that although PE was frequently mentioned, its purposes, elements and conduct were poorly documented. Stakeholders involved in the design, approval and execution of PE in clinical trials were interviewed and expressed differing views on possible remote assessments. The findings of this thesis support the decentralisation of clinical trials. Future DCTs should incorporate the needs of patients at every stage of the trial to reduce potential barriers to participation.