Centralized vs decentralized clinical trials; what’s the difference? Clinical trials allow researchers to collect data and analyse the results, which can provide invaluable insight into how well treatments work. Clinical trials are generally divided into two different types: centralized and decentralized.
Centralized trials are widely used in clinical research. However decentralized clinical trials are becoming more common as they are more flexible and allow researchers to collect patient data remotely, as explained by ObvioHealth (https://www.obviohealth.com/resources/decentralized-clinical-trials-a-comprehensive-synopsis).
This post will discuss the pros and cons of centralized vs decentralized clinical trials, and it will help you decide which type of clinical trial is best for your research.
The History of Clinical Trials
You might be surprised to know that we’ve been conducting clinical trials (in their most basic form) since 500 BCE.
There is a biblical reference to a trial run by King Nebuchadnezzar, who wanted to see which diet was better: a meat-and-wine diet or a vegetable-based diet. The trial ran for ten days, after which point the test subjects who ate a vegetable-based diet were deemed healthier than the other group.
Fast forward to 1747: Dr. James Lind conducted what many consider to be the first controlled clinical trial. He wanted to see what could be done to reduce the appalling rate of scurvy amongst sailors, and his study led him to rightfully conclude that eating lemons and oranges had the greatest healing benefit.
By the early 1800s, the placebo effect had emerged.
By 1943, we had our first double-blind controlled trial with the first randomized curative trial arriving about three years later.
What Is a Centralized Clinical Trial?
A centralized clinical trial has one location with a single administration and a smaller scope of patient recruitment.
Up until relatively recently, all clinical trials were considered centralized. But with the increasing efficiency of telemedicine and digital technology, the decentralized clinical trial is increasingly being adopted and is considered the way of the future, even in a post-pandemic world.
What Are the Challenges of Centralized Clinical Trials?
The main challenge with trial centralization is patient recruitment. Depending on where the trial is being held, the pool of possible patients or test subjects is inherently limited. Patients may lose interest in participating in this type of trial if they have to travel far to get to the site.
Another challenge is funding. Sponsors can lose millions of dollars if a clinical trial is taking too long to complete—which leads us back to the first issue of recruitment. Some centralized clinical trials have even stopped altogether because sponsors have dropped out.
What Is a Decentralized Clinical Trial?
A decentralized clinical trial involves a range of practices and solutions that utilize online technologies to carry out a wide range of studies. The term has been hard to define because not everyone agrees on the definition, and it is often used interchangeably with the words mobile, remote, and virtual.
The biggest difference between centralized vs decentralized clinical trials is patient accessibility and ease-of-access. Decentralized clinical trials (or DCTs) encourage patient participation from various locations outside the test site.
Since the start of the COVID-19, DCTs have proven their efficacy and efficiency, showing that the benefits far outweigh whatever challenges healthcare providers may face to undertake a remote clinical trial.
The Process of a Decentralized Clinical Trial
While the trials themselves will be invariably different, DCTs are all conducted using a very similar process:
- Patients are recruited from various locations and are then screened virtually.
- Patients are given access to an app or other digital tool where they can record data from anywhere.
- Patients are sent notifications and helpful information to keep them engaged.
- Patients visit the trial site on some occasions for in-person clinical care.
Advantages Of Decentralized Clinical Trials
The biggest advantage of DCTs is that it’s patient-focused, and provides better representation for people living in remote areas or who come from marginalized communities. DCTs encourage a wider range of patient participation, which gives us a better scope of research and leads to improved healthcare for everyone, no matter their age, gender, ethnicity, or income level.
Decentralization of clinical trials also allows clinicians to communicate with and check in on their patients on a more regular basis. This does require patient participation, though patients may be more likely to submit their data when they can easily use the technology and don’t have to travel to do so.
A huge benefit of adopting the DCT method is the potential for sponsorship. Because DCTs enable a broader scope of subject participation, researchers can conduct their trials on time and with better data, thus demonstrating the value of their research.
Decentralized Clinical Trials Challenges And Obstacles
DCTs do come with their own set of challenges, and many of these are caused by how complex the process is and how many stakeholders are involved. The DCT is still in its budding stage, so at this time, standards for conducting and participating in DCTs are not regulated.
Another huge challenge of DCTs is ensuring that all the moving parts are working in harmony. Whereas centralized clinical trials don’t necessarily rely on patient-facing data-collection technology, this is central to the success of a DCT.
As a patient-centred approach, it’s important for stakeholders to develop a deep understanding of their patients to find out if decentralization is better for them. For example, some patients prefer on-site check-ups and not every test subject will be sufficiently well versed in technology to make app-based data collection a user-friendly experience.
The Bottom Line with Centralized vs Decentralized Clinical Trials
While DCTs are still in the early stages, the critical role decentralization has played during the pandemic has shown improvements in data collection and patient experience. While we will likely always need centralized clinical trials in some capacity, the efficiency, scope, and patient-centred approach to decentralized clinical trials makes it the most economical and sensible solution for clinicians and researchers.