Centered on Decentralized Trials: Q&A With Harpreet Gill, Head of Decentralized Clinical Trials at Icon

Harpreet Gill, head of decentralized clinical trials (DCTs) at Icon, is working to make DCTs more easily implemented and more commonly used throughout the industry. She recently spoke with Pharmaceutical Executive about her work.

Pharmaceutical Executive: Can you explain the importance of decentralized trials?

Harpreet Gill: Over the last few years (and we know the pandemic accelerated this) there's been a greater need to think about the different ways to engage patients in clinical trials. There's an element of efficiency there in terms of how data is collected. One of the things that we are seeing is that there are more clinical trials, but there aren't as many patients interested in being involved because it can be difficult to participate. We do need more patients, but we also need greater diversity as well. All of those factors are now really driving the importance of decentralized clinical trials in the in the clinical trial setting. Also if you take a look at healthcare generally we are relying more and more on digital tools. Folks are more interested in managing their own healthcare and I think we need to take a look at how we can use and manifest and surface that in a clinical trial setting as well.

PE: What struggles have you faced trying to implement DCTs?

Gill: There are a number of hurdles that we face when trying to implement decentralized clinical trials. Firstly, it's a making sure there's good understanding of what we mean by decentralized clinical trial. There are a lot of definitions out there. Some people think it's telehealth, some people would say it's consent, and others think it's about carrying out one or more of the assessments that would normally happen at an investigator site away from the site. So, making sure that people understand what we're trying to do in that context can be a little bit of a challenge. There is definitely some education that needs to be done for sites, patients, and sponsors while also helping the regulators understand what we're doing and how we're trying to implement DCTs. That's a work in progress.

Also from a technology perspective, some of the technologies that we want to use are novel, so to ensure that they'll work well and that they're operationalized from an end to end perspective, you need expertise, which hasn’t always been available in the past. That is changing, but it's a work in progress. It's not something that you can resolve immediately when you're using a completely different technology. It's important to think about investing in pilots and engaging earlier with doctors, patients, and sponsors who are willing to give things a go early on before you've got everything proofed out.

Then there's the sites and their view on decentralized clinical trials. Our experience is that they are interested but concerned about how this will work just in terms of the day-to-day management of the clinical trial. What does that mean in terms of their responsibilities and accountabilities? It's a business for many sites, so how does this affect their business model? There are some of the things that we're trying to address.

PE: How important is it to have good communication among these sites and how do you build that communication?

There are a number of ways. We need to ensure that the sponsors are fully engaged, and work with the sites from the outset, remind them that this is going to be a DCT or a hybrid study and that they'll be novel technologies used. This also involves gauging their expectation, enrolling them into the process, and getting an understanding of their concerns. It also includes making sure that when we look at the site contract, we ensure that they are going to be properly reimbursed for what they need to do as far as the trial is concerned. We're able to offer direct support for the sites as they go through the clinical trial, both in terms of providing training for them and a concierge support team who can engage with the site and ensure that the site understands that if they've got questions about the technology and how things are progressing, they've got someone to reach out to, almost an extension of the of the study coordinator. These are some of the ways that we can engage with them to support the level of comfort they have with DCTs.