RDCTs have features that increase the importance of patient, or participant, engagement e.g. less face-to-face human contact, more participant responsibility, and using unfamiliar technologies. Facilitating and supporting engagement while keeping the focus on participants should be considered at all stages of trial decision making.
The key selection criteria for planning and conducting a remote decentralised clinical trial are described in the diagrams and flow charts to follow. The selection process is presented separately for each basic building block representing the stages of the clinical trial process (Figures 1-7). The selection criteria herein represent the main considerations to help guide the decision in choosing a remote, hybrid, or traditional clinical trial method that is most appropriate for your study. This document is designed to be read in conjunction with D1.1 First set of recommendations (to be implemented in the pan-EU pilot RDCT). The recommendations contain more detailed guidance to facilitate decision making.