Within the trial’s community, we are regularly talking about more efficient designs such as adaptive designs and decentralising elements of trials. These in turn can improve trials for patients and those involved in the design and conduct. Clinical trial design and execution is evolving to ensure efficiencies and there is a continual learning curve for trialists. In this blog post, I will introduce you to an emerging way of conducting trials called decentralised clinical trials (DCTs). I will break down the key ideas of DCTs and discuss the terminology. The aim is to encourage you to think about implementing or participating in these types of trials whether involved in designing and delivering trials or a potential participant.
What is a DCT?
A DCT shifts away from the notion of a central site serving as the focal point of the research; instead opting for completion of the study at participants' homes or local environments. Non-patient related trial activities also can be decentralised, for example conducting site training online. I will refer to the different ways of decentralising a trial at its different stages as ‘elements’. Elements might include allowing participants to consent and be randomised remotely, remote intervention delivery as well as remote data collection and monitoring.
DCTs, or the elements of them, have been around for some time but there has been a rise in popularity since 2020, aligned with the COVID-19 pandemic which is having an impact on the clinical trial landscape.
Approaches and Considerations for Decentralising a Trial
Decentralising a trial allows for flexibility along a spectrum; it need not be a binary decision between all decentralised or no decentralising (Figure 1). There can be fully DCTs where the whole trial is conducted using decentralised elements, and hybrid when only some elements are decentralised. It is important that a trial describes what decentralised elements they are using.
Figure 1 Scale of Decentralisation
Figure 2 highlights a small range of decentralised elements that are available to researchers throughout the trial lifecycle. For each stage of the of the trial there are choices about what elements to use and how much to use them, much like adjusting a lever. The level of these levers defines the ‘degree of decentralisation’ for each trial. DCTs are less suited to some diseases and interventions such as interventions delivered in a critical care setting or a surgical procedure, but there is usually room for a degree of decentralisation for some of these elements in all trials. For example, in critical care and surgery trials, we can use Healthcare Systems Data for long-term follow-up data collection.
Figure 2 Elements that can be used at each step of the trial lifecycle.
DCT terminology across key stakeholders
The definitions of DCTs in the literature vary across regulators, funders and academic and industry researchers. Regulators such as the EMA, FDA and NHS HRA tend to focus on the patient’s home being the location where the trial is taking place. While this is a main focus of a DCT they can also employ elements such as use of Healthcare Systems Data such as, NHS Digital or patient registries, where follow-up information is collected via electronic health records rather than at the patient’s home. Definitions from industry emphasise patient centricity. The Association of Clinical Research Organizations (ACRO) highlight how DCTs intend to ‘bring the trial to the patient’, McKinsey stresses patient needs and IQVIA discusses ‘flexible patient and site strategies’ (1–3). The NIHR’s definition of a DCT stands out as they suggest that a patient can choose how to interact with the trial e.g. choosing if they want to attend a visit in person or remotely. While this could be possible and might have been implemented in some trials, this does not seem to be a definition shared with other stakeholders.
I will be conducting my PhD in the area of Digital Health and DCTs are an area that is bringing together digital technology. During my preliminary research, I have formulated the following definition, which captures the essence of this trial design and will be adopted for my research moving forward.
The aims of my PhD will be to provide an overview of DCTs worldwide, assess patient acceptability of these designs and optimise the use of longitudinal data sources for data collection within these trials. My next step will be to carry out a systematic review and I hope to share more blog posts over the course of my research. I hope this blog will encourage you to think about using or engaging with DCTs.
This research was funded by the NIHR Imperial Biomedical Research Centre (BRC). The views expressed are those of the author and not necessarily those of the NIHR or the Department of Health and Social Care.
References
ACRO. QbD Manual for Decentralized Clinical Trials: The Quick Reference Guide [Internet]. 2023 [cited 2024 Mar 20]. Available from: https://www.acrohealth.org/qbdguide/
McKinsey. Stepping up the decentralization of clinical trials [Internet]. [cited 2024 Mar 20]. Available from: https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials
IQVIA. Proven, flexible DCT solutions [Internet]. [cited 2024 Mar 20]. Available from: https://www.iqvia.com/solutions/research-and-development/decentralized-trials
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