Remote methods in clinical trials

Abstract

Inclusion of remote trial activities in study designs could potentially reduce some of the recruitment and retention issues currently associated with clinical trial conduct. Little is known about the extent in which remote activities have already been implemented in trial protocols, therefore this study quantified the reporting of remote methods in phase 2, 3 and 4 interventional clinical trial protocols in a cohort of studies with study start in 2019 and 2020. Additionally, an interview series into direct-to-participant investigational medicinal product supply was conducted to gain insights into stakeholders’ experiences with implementation of this remote trial activity in the European Union. Remote methods were found to be reported infrequently, with the exception of remote data collection, and an increase in inclusion of remote methods in 2020 protocols compared to 2019 was observed. Furthermore, this study found that, amongst others, staff training and outreach are often not reported in protocols. In terms of direct-to-participant supply, unharmonized regulations were found to be a big barrier in Europe, as, for instance, the depot-to-participant model can only happen with a pharmacist present. Moreover, interviewees emphasized a need for flexibility in trial designs, and called for more collaboration amongst stakeholders. Overall, this study shows that remote methods have already been included in study protocols, and that stakeholders are positive towards additional exploration of the opportunities of including remote methods such as direct-to-participant supply in (European) trial designs.