What Are Decentralised Clinical Trials?

Decentralised clinical trials are a type of trial design used by studies to collect data from their participants. How data is collected can impact the trial’s efficiency, accuracy, and overall success and outcome. So, having the right approach to the design of a clinical trial can have a big impact.

In this guide, we explore what decentralized clinical trials are, as well as their potential benefits and challenges they present to clinical research.

What Are Decentralised Clinical Trials?

Unlike other types of clinical trials, namely centralised clinical trials, decentralised trials don’t require participants to attend study sites for assessments and monitoring. Instead, they allow people to participate in research activities at a time and place that suits them.

This type of study usually encourages patient participation by reducing the need to attend a clinic or hospital.

A hybrid DCT uses both sites and remote locations, usually relying primarily upon data collected outside a site visit. This is currently the most common type of decentralised trial being implemented.

Decentralised trials have only been made possible through the advancement of technology. The industry was initially slow to adopt the decentralised paradigm, but the challenges of the COVID-19 pandemic have brought it into greater focus. Moving to a virtual and direct-to-patient approach is the new norm, with over 79% of CROs and sponsors declaring an increase in their use of decentralised trials in 2020.

What Are The Advantages Of Decentralised Clinical Trials?

There are significant benefits of DCT trials to both subjects and sponsors alike.

Reduction In Costs: Reducing or eliminating the need to schedule visits and travel to and from clinical sites reduces the cost compared to traditional trials.
Real-Time Data: Participants can report symptoms in real-time, and researchers can send out reminders for study activities.
Participant Engagement: This, coupled with decreased travel, tends to keep participants engaged.
Improved Safety & Efficacy: For the sponsors, decentralised trials bring immediacy to the data, allowing greater safety oversight and standards of care,
Increased Participant Pool: Collecting data remotely allows participants from remote areas and otherwise unavailable geographies.

What Are The Cons Of Decentralised Clinical Trials?

Despite the benefits of the decentralised trial model, there can also be several challenges for researchers and sponsors.

Trials rely on technology to support out-of-clinic data collection. The industry cites the lack of suitable technology as one of the main challenges to the adoption of decentralised trials. This challenge is becoming more accessible and can be overcome with technological advancements like devices, smartwatches, and other solutions. However, it is still a barrier for some studies that need careful consideration in the design phase.

Other Types Of Clinical Trials

Decentralised trials are one type of study that researchers can use to test new drugs and therapies. However, there are other options, such as centralised and virtual clinical trials.

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