By, Simon Taylor, Principal KOL & European Strategy Lead @ Florence

What is a DCT?

The Decentralised Trial (DCT) operating model offers a departure from the traditional “patient goes to site” approach. This novel approach improves patient access, especially for those who may have been unable to attend a site previously.

In the recent past, the idea of Decentralised Trials was centred around using technology to achieve its goals. Still, this approach had the downside of having a “technology at all costs” mindset. While technology is a great tool, it should not be prioritised over the needs of those who use it the most, namely the sites. Nowadays, we are witnessing a change in how DCTs are implemented in practice, where it is no longer assumed that only technology will provide all the answers, but rather a shift to a more balanced approach.

So now we know that information, how can you be closer to DCTs when heavily reliant on paper? Let’s talk about it.

You’ve got paper? So what

The assumption with a set of processes heavily reliant on paper is that you can’t work with DCTs, you don’t work with certain sponsors, or ignore research, right? Not necessarily. 

In order to provide patients with the best care possible, we must use innovative approaches, which sometimes involves utilising technology beyond what you may be accustomed to. However, this doesn’t mean you’ll suddenly find yourself in a futuristic world like Minority Report. The main goal of a DCT is to simplify the patient’s life as much as possible. Nevertheless, there are still many trials that require the physical presence of the patient. Therefore, it’s essential to communicate with your sponsors about their vision of how the trial will operate and provide your valuable input in the process.

Effective communication is crucial in ensuring the success of clinical trials. It is essential to comprehend the purpose of the trial, rather than just focusing on the technology used. Currently, DCTs are most successful in studies that do not involve significant interventions. However, the principles of DCTs will eventually extend to studies that are intervention-heavy. For instance, if you have patients who are bedridden, it may not be feasible to introduce new technology that can improve their quality of life. Nonetheless, your sponsors may want to explore the possibility of monitoring such patients remotely, from a home care setting.

Where to Start with Technology

One of the most challenging places to start is trying to understand where you need technology the most. Typically, it isn’t going to be in a study-specific tablet or a cumbersome-to-use EDC configuration. These don’t always have the desired impact because they are sponsor-driven.

The most important question is simple: “What will have the biggest impact?” Look around at the paper and see where most of it is; that’s where to start. Often, this looks like an Investigator Site File, Electronic Signatures, eConsent, and EHR.

What drives real impact for both the site AND the sponsor is technology that inherently enables the site to do their best work when the site chooses it.

Community

One of the most challenging parts of modern research is the ability to have a patient community truly represented within a study. The patients that come into a clinic/site may not fully represent the demographics of the area you serve; they may not also encompass everybody who suffers from a given condition. It may just be those who can get to a hospital and who are willing to consent to research.

In theory, the concept of a DCT should help identify and recruit these patients, but we all know you can’t just say, “Hey, you’ll get an iPhone to input your data,” and magically, everyone will appear.

What the concept of a DCT does allow you to do is be more creative with recruitment. Many people we speak to use it as an approach to get out into the communities; using tools like Electronic Consent (eConsent) and electronic registries to advertise in places such as fairgrounds and community areas, and use them as electronic recruitment centres. This approach sounds relatively simplistic, but it’s an intelligent use of technology to aid in solving the recruitment challenge.

Summary

DCTs initially promised much in terms of technological advancement, but this was a misunderstanding of the concept; it’s about the operating model to benefit patients as much as possible whilst providing downstream improvements for Sites, CRO’s and Sponsors alike.

When you are paper-heavy, it shouldn’t deter you from seeing any benefit or interacting with sponsors who are very DCT-conscious. Instead, it allows you to use its advantages to identify more patients in your community and become more intelligent regarding recruitment methods. 

We should never ignore the amount of paper in our industry; pretending it’s all okay would be a mistake. However, we should always focus on the largest benefit, where paper can most easily be eliminated. It can start with something like paper binder rooms, removing the archive headache, stopping printing patient records, hand signing documents and physically tracking where a document is; it doesn’t need to be that way. 

Don’t let DCTs scare you into making a seemingly frightening decision; the first step should always be what benefits you the most.