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Are digital decentralized clinical trials the future?

If there is one thing that we have learned more than anything else over the past couple of years it's that we can do most things remotely. Clinical trials are no exception, with new reports stating that many trials, like those offered by Clinical Ink, are able to be done remotely without the need to stay at a residential center for the duration.

In this article, we'll explain what digital decentralized clinical trials are, how technology has helped lead this shift, and what the future could hold for us regarding digital clinical trials.

What are digital decentralized clinical trials?

A decentralized clinical trial is just a regular clinical trial that takes place in different locations instead of one central location. A digital decentralized trial is the same but with the added benefit of being able to track the data digitally and collect it remotely.

The term 'digital' refers to the use of technology to implement this type of study, whether it be using a mobile app or using a tablet or laptop computer during an in-person visit. The goal of this technology is to allow more flexibility by allowing trials to take place outside of a hospital setting and even perform them remotely if necessary.

The huge improvements in technology, especially wearable technology, have meant that now more than ever, these kinds of trials are a viable way to get potentially life-saving data. Trials and experimentation have led to some huge developments in recent years, and it's hoped that digital clinical trials could help bring about the next wave.

What has the journey to digital been like?

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The development of digital decentralized trials has been a slow process. The first step was to find a way to track the data remotely so that it could be more easily collected. This was done by creating an electronic medical record (EMR) to centralize the data and allow it to be accessed anywhere.

In order for this EMR technology to work, though, researchers needed something that would allow the EMR software and devices to communicate with each other without automatically sending the entire medical history of patients at once

Next up was figuring out how best to collect this data from patients in different locations while still keeping them safe and anonymous. This led us down the path towards developing systems that use unique identification numbers instead of patient names or initials like we're used to seeing on paper forms and trial registries.

Once all this groundwork had been laid, some obstacles were left before we could truly do decentralized trials entirely digitally. Methods had to be found to ensure that sensitive health care information stays secure online when transferred between doctors, patients, trial coordinators, and research sites. We had to discover the best way to deal with varying levels of connectivity, ensure sufficient internet coverage during all hours, and address regulatory requirements. In addition, we had to educate doctors about using these technologies and train participants on using them.

The list of challenges that researchers faced was almost endless, but you get the idea! All these issues have now been addressed or are being worked on today, allowing us now see widespread adoption of digital decentralized clinical trials taking place around the globe!

What does all this mean for researchers?

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For one thing, it saves time by reducing travel costs, for example, when a doctor would previously make multiple visits just because they were unable to share visit notes electronically outside of face-to-face visits. It also leads to fewer interruptions in care which allows for better patient compliance with the treatment regimen and results in a better overall clinical trial.

An additional upside to this remote method is that researchers and doctors will be able to observe participants in natural conditions and make observations that are more reflective of what can be found in the real world.

What does all this mean for patients?

Patients no longer need to give up their valuable time to participate in clinical trials, so more can do so, especially those who live far away from trial centers. This benefit is especially helpful when dealing with rare diseases that don't have many participants locally and need as much participation as possible.

Being able to track your data remotely means less downtime where you're unable to perform your daily activities because of frequent monitoring appointments and also gives you some control over your own health by providing you access to your information when you want it.

The future of digital decentralised clinical trials

Although early adopters of digital decentralized trials have been mostly based in the US and Canada, we're seeing signs that they're becoming more popular outside these countries, such as in India, the UK, Japan, Australia, New Zealand and Mexico.

With more studies now being done digitally rather than at a centralized location, there will be even more opportunities for researchers across the globe looking for participants who would otherwise not be eligible.

We can now also expect cost savings due to reduced travel expenses associated with these types of studies as well as opportunities for smaller centers, without the resources or staff needed to run trials on their own, to become involved by collaborating on larger projects.

As technology continues to advance, we'll likely see digital tools continue to improve, allowing us to test new drug therapies more quickly while still maintaining high-quality standards. This is definitely something to keep an eye on and even get involved in if you feel up to it - the potential upsides are unimaginable.