Trials industry needs to settle on terminology for decentralized studies, says report

Unclear terminology is slowing the uptake of remote trials according to a study that suggests using “decentralized” and “patient-centric” interchangeably causes confusion.

The study – published in the journal Drug Discovery Today – looked at the various terms being used to describe drug studies that allow subjects to take part at home in published studies and found that usage varies considerably.

Terms used to describe decentralized clinical trials fall into several broad categories: those focused on the patient; those focused on the location of the study being conducted; and those focused on the technology involved.

However, even within these categories, the scope of each usage differs study-to-study.
And this lack of uniformity is a potential problem according to the authors, who wrote “this lack of standardized terminology can cause confusion over what a particular trial model entails and for what purposes it can be used, hampering discussions by stakeholders on its acceptability and suitability.”

Choices

To address this, the authors suggest industry needs to choose one of the most commonly used terms– remote, virtual and decentralized. However, as they point out, there are advantages and disadvantages to each.

For example, they suggest the term “remote clinical trial” can be confusing because trial activities are not conducted remotely from the perspective of trial participants, rather they are remote from the trial site.

Similarly, the term ‘virtual clinical trial’ is also used to refer to in silico trials and studies aimed to simulate pharmacokinetic and pharmacodynamic outcomes using historical patient data as opposed to prospective interventional clinical trials.

In addition, as the authors point out “the Danish Medicines Agency states that the use of ‘decentralized clinical trial’ is not synonymous with ‘virtual clinical trial’ because the latter is considered as retrospective data processing without participants.”

The authors’ preferred choice is “decentralized clinical trial” even though they admit it neither highlights the envisioned benefits for participants nor suggests trial activities are centralized from the participant’s perspective.

“To ensure clear and effective communication among all stakeholders involved in clinical trials that use technologies and other innovative operational approaches to bring the trial closer to the patients, we call for the consistent use of ‘decentralized clinical trial’.

“By adopting a unified terminology, we can avoid confusion and facilitate productive discussions on the implementation, benefits, and (potential) disadvantages of decentralized clinical trial approaches.”

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