Why is the uptake of decentralised elements in clinical trials slower than expected?

In the swiftly changing realm of clinical research, incorporating decentralised elements into clinical trials is becoming a transformative approach to drug development. Driving this approach is the need to not only improve the desirability of participating in clinical trials by reducing participant burden but also increase the utility of the data/evidence collected. The philosophy guiding this approach is both participant- and site-centred, thus ensuring decentralised elements truly add value to the clinical trial experience while still meeting a trial’s scientific objectives. As the potential benefits of these innovative trial methodologies have become more clear, regulatory agencies worldwide have released numerous guidelines for incorporating decentralised elements into clinical trials. Despite these promising benefits and regulatory guidance, the adoption of these elements has not progressed as rapidly as anticipated. This commentary delves into some of the factors sponsors consider with regard to integrating decentralised elements into clinical trials and discusses several challenges they face in practice.