Decentralised clinical trials: A new approach with opportunities and challenges

Clinical trials are dependent upon the availability of participants who are willing and able to take part in them. At times, however, participating in a clinical trial requires a significant amount of time and travel. The aim of decentralised clinical trials (DCTs) is to move some of the trial-related visits and/or assessments from the trial site to a participant’s home in order to reduce practical barriers to trial participation and to more smoothly integrate study visits into participants’ daily routines. While DCTs open up new opportunities for trial participants and researchers, they also pose challenges in terms of ensuring both patient safety and adequate oversight as well as protecting participants’ data privacy. Swissmedic recommends that researchers take an active approach by engaging in the current dialogue on DCTs and liaising closely with the authorities as they plan and conduct DCTs in order to ensure they fulfil applicable legal requirements.