Decentralised Clinical Trials

Clinical research protocols are likely to increasingly incorporate elements of decentralisation, as characterised ‘by less dependence on traditional research facilities or specialist intermediaries for data collection’.[1] Key benefits of decentralisation have been explained as reducing the burden of participating in clinical trials, potentially facilitating recruitment, and increasing the diversity and subsequent generalisability of the trial findings.[2] CT:IQ stakeholders identified supporting decentralised clinical trials (DCTs) as a key issue for improving the quality, efficiency, and effectiveness of clinical research.

In Australia, considerable funding and effort has been given to establishing a national model for teletrials. However, less is known about resources available to support other models for decentralisation. For this reason, CT:IQ has partnered with Dr Tanya Symons identify the toolkits and other resources that already have been developed in Australia. The mapping exercise will help to inform future CT:IQ activities in this space, as well as serving more generally as a resource for the Australian clinical research community.

 

[1] Yared Santa-Ana-Tellez and others, ‘Decentralised, Patient-Centric, Site-Less, Virtual, and Digital Clinical Trials? From Confusion to Consensus’, Drug Discovery Today, 28.4 (2023), 103520 <https://doi.org/10.1016/j.drudis.2023.103520>.

[2] Santa-Ana-Tellez and others.