Used in the right way, decentralization can help put patients at the heart of a clinical trial. But if a fully decentralized or hybrid trial is designed and implemented without considering participants’ perspectives, it can result in gaps in data, low participant retention and delays.
In a recent article, Siron Clinical CEO Jan Balemans wrote about the link between decentralization and patient centricity, highlighting that it’s not as simple as we may think. While decentralization can save time and money and even appeal to patients who can participate from where they are, it’s not always desirable.
Here are three things to focus on if you’re considering decentralization for your clinical trial, to help maximize patient centricity.
1. Learn and adapt to patients’ habits and routines
Imagine you want to collect heart rate data 24 hours a day for a certain period using smartwatches. This seems simple: you can send patients a package with a watch and instructions and get ready to process the data.
In reality, though, any number of issues could arise. One of the big problems might be related to participants not being used to wearing a watch.
In his article, Jan wrote: “As a participant, I receive my watch, read and understand the simple instructions that I have to wear it constantly for two weeks, and I put it on. But at night, I get ready for bed and automatically take it off before I go to sleep. It’s subconscious – I always take my watch off before bed.”
This example shows that before you decide on the approach, it’s important to talk to patients and understand their routines. What might be potential hurdles for them? Even if you still decide to take the same approach, this can help you adjust things like instructions and communication methods, ultimately making it more comfortable for participants. Learning and adapting to patients’ habits and routines is key.
2. Understand why patients enroll
If you have a potentially life-changing intervention, it’s tempting to assume patients will want to enroll on your clinical trial to access it. But reasons for enrolling run deeper than that.
For example, Jan points out the changing demographics – specifically that the population is ageing. This has implications for use of technology in a decentralized trial, but also reasons for enrolling.
Jan: “In my experience, older people often see contact with health practitioners as being a major benefit of enrolling in a clinical trial and often a reason to do so. It’s therefore even more important to consider the people and their needs before looking at technology and feasibility.”
If people’s reason to get involved is closer in-person contact with a health practitioner, it might be worth reconsidering decentralization. Two frameworks can support decisions around this: the Geriatrics 5Ms (medications, mind, mobility, multicomplexity, and what matters most) and 5Ts (target population, team, time, tips to accommodate and tools).
3. Design a communication plan to suit participants
If you have looked at the trial from the patients’ perspective and determined that decentralized elements are appropriate, there may still be challenges. For example, participants might struggle to use unfamiliar devices and platforms.
With the right approach to communication, you can make sure decentralized elements are improving, not harming, patient centricity. Again, from the patients’ perspective, think about the challenges they might encounter, the questions they might have and the moments they might need support.
For example, in a trial using smartwatches, participants might need a hotline to talk to a trial team member if the watch malfunctions, to ensure they feel supported and there are no gaps in your data. They might also want regular check-in moments with a phone or video call to provide real connection.
AI applications are also entering widespread use for communication, including in healthcare. Chatbots could save you time and money and they can provide participants with a range of support and information. But if participants prefer human contact, using an AI application might have a negative impact on your trial.
The key is to know your audience – your participants – and communicate in a way that gives them a positive experience.
How are you using decentralized elements to put patients first?
In his article, Jan talked about the ongoing conversations around decentralization focusing mainly on feasibility and compliance and he pointed out that we need to pay more attention to the interaction between decentralization and patient centricity.
“The link between decentralization and patient centricity isn’t simple and we shouldn’t assume it is when we’re designing and running clinical trials” he wrote.
Siron Clinical has been working on decentralized trials for more than 15 years. Siron can build the approach you need for your decentralized trial, starting with what’s best for your participants. Find out more.
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