Clinical trials are, and will remain, crucial in drug development and improving patient health. However, (s)low patient recruitment and low retention puts pressure on the efficiency, generalisability and validity of traditional, clinical site-centred trials. Decentralised Clinical Trials (DCTs) hold the promise of solving this problem.
The DCT approach is an operational strategy for technology-enhanced clinical trials, that are more accessible to patients by moving clinical trial activities to more local settings. DCTs can be applied in all stages of the drug development process, to generate evidence on safety, efficacy (as traditionally obtained from controlled phase I to IV clinical trials) or effectiveness (as obtained from more pragmatic studies aimed at guiding prescribing in routine clinical practice).
The Trials@Home consortium will explore the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These so-called Decentralised Clinical Trials (DCTs) make use of new – digital – innovations and enable participants to visit a clinical trial centre less frequently, if at all. This makes it easier for larger, more diverse and remote populations to participate in clinical trials. These trials are expected to be conducted faster, more efficiently, and provide results that are more representative, because the data is collected in the daily context of the participant (Real World Evidence). The research to be conducted includes an inventory and evaluation of existing and new techniques for use in DCTs as well as a pan-European pilot trial.