What are Decentralized Clinical Trials?

If you want to understand how decentralized clinical trials work, read our article for an in-depth overview of everything you need to know.

Our need for remote scientific research methods has increased significantly in recent years. Despite a worldwide reduction in lockdown levels and isolation protocols, the adoption of ‘virtual healthcare’ systems has continued to grow across all fields of medical research.

What are Decentralized Clinical Trials?
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In terms of beneficial influence, decentralized clinical trials have been the most significant contributor to the rising popularity of remote research. To understand how these trials work, it’s worth taking a look at what defines them, how they benefit medical research, and why they’ve become preferred systems of scientific inquiry.

Defining decentralized clinical trials

Clinical trials are scientific studies that are performed for medical research. This research covers a wide variety of medical fields, such as those related to heart, lung, blood, and sleep disorders. Studies are typically based on a random sample of subjects with the aim of finding new ways to combat prevalent diseases.

Decentralized trials are defined by their remote nature. For the most part, they don’t require trial participants to visit a central research site. Unlike centralized trials, they bring the majority of a trial’s activities directly to the patient.

The recent pandemic was a primary cause for the adoption of remote systems of research. Due to a lack of access to trial sites, technologies that could assist with remote patient monitoring and virtual assessment became critical counters to the reduction in trial participation.

The mobile technologies provided by telemedicine, combined with integrated networks of mobile and local healthcare providers, allowed decentralized trials to speed up the process of research. This efficiency has been the primary cause for their continued growth, but there are additional benefits that have been brought about by these trials, the majority of which are covered briefly below.

Advantages of adoption
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Advantages of adoption

By improving the efficiency of clinical trials, decentralized research elements put patient needs first and foremost, and trial sponsors are continuously finding that decentralization not only fulfills that philosophy but also improves the experience for all parties involved.

Trial participants don’t have to worry about traveling anywhere, which has the added benefit of providing sponsors and investigators with a greater pool of patients to choose from. It also reduces the workload for service providers by adding methods of data collection that don’t require a central trial location.

Additionally, removing the need for a central location frees up clinical resources that can then be used elsewhere, such as drug administration staff and data verification personnel. Reports of high retention rates have been witnessed in all tests of its efficacy, proving that decentralization is more than just a topical solution.

Thanks to electronic consent tools, remote monitoring apps, and other mobile technologies, entirely virtual trials have a diverse range of applications. However, virtual models that are completely remote are still relatively rare, with most trials nowadays utilizing a hybrid model.

According to most health experts, hybrid models will likely become the preferred method of research in the future. These models take the best of both centralized and decentralized models, adopting research elements according to whichever model benefits relevant research objectives the most.

decentralized clinical trials limitations
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Limitations of decentralized trials

At this point, we’ve established that hybrid trials will likely become the standard model for most clinical research. There’s no doubt that entirely virtual trials have their uses, but it’s unrealistic to assume that they can be used in all fields of medical research.

For example, decentralization isn’t able to assist with complex procedures that require specialized equipment, such as magnetic resonance imaging (MRI) and computed tomography (CT) scans. What’s more, many remote healthcare providers lack the resources to own, let alone maintain, such sophisticated equipment.

The quality of data extracted from decentralized trials is still up for debate. Unlike centralized trials, decentralized models rely on technology that lacks appropriate regulation, mainly due to the rapid rate at which mobile technologies develop. That’s not to say that the data isn’t worthy of analysis, but it does call into question the accuracy of any given results.

In time, regulatory standards will ensure that apps and wearable devices meet the requirements for technical and clinical validation. For now, however, that responsibility remains in the hands of research sponsors.

Facing a unique opportunity to drive change toward trials that could benefit trial participants and sponsors alike, the clinical-trial industry has to figure out a way to match the pace of technological development with the advancement of relevant laws and legislation.

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In order to ensure that clinical trials remain as comprehensive as possible, participation for patients and physicians should be convenient and sustainable. This will require the adoption of strengths from all trial models, regardless of whether they have centralized or decentralized elements.

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Dr. Melanie Greenberg, Ph.D.

Melanie Greenberg, Ph.D., a practicing psychologist in Mill Valley, California, is an expert on stress, the brain, and mindfulness. She

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