Catherine Gregor
Chief Clinical Trial Officer
Florence Healthcare

Cari Kniola
Senior Director, Corporate Strategy
Aperio Clinical Outcomes

September 8, 2022

Everyone is talking about the benefits of decentralized clinical trials for patients. But what about the sites?

The shift to decentralized clinical trials is forcing trial sites to rethink their entire workflow, from how they recruit and engage patients, to what their contracts include, and what technical skills their teams will need. For decentralized clinical trials to become a permanent part of the clinical research culture, sponsors need to consider how these models affect sites, and what they can provide to help them ease the transition.

“You can put technology at a site, but if it doesn’t flex to their workflow, you’re going to have adoption issues,” says Catherine Gregor, chief clinical trial officer for Florence, the industry leader in remote connectivity in clinical research. “It is important to come at it from a site-centric perspective.”

Gregor recently participated in a round table discussion with Cari Kniola, director of corporate strategy, to talk about the role sites play in decentralized clinical trials (DCTs) and what sponsors and CROs can do to create a site-centric environment so that everyone benefits. Here’s what they had to say.

What is a site-centric perspective?

Gregor: It means looking at site workflows and talking to sites about what makes sense from their perspective versus the sponsor’s perspective. Giving sites a chance to say ‘Here are some things from your workflow that caused problems in the last study. And can we figure out a mutually beneficial way to solve that problem?’ Coming at the technology from a site-centric perspective is going to give sponsors all of the outcomes they want and fewer headaches around managing workflows that are not native to the team. So I think a lot of sponsors are open to these conversations.

Kniola: Sites just want a seat at the table and to be part of the conversation about the overall movement toward decentralized trials. So, let’s talk to the sites and see how running a DCT will impact them and factor that into trial designs and technology adoptions. Because in the end, without the sites, you don’t have a study.

What concerns do sites have about DCTs that no one is talking about?

Kniola: Sites aren’t opposed to the DCT technology and making decentralized trials work. But it can create more work for them, and it is important to talk about that. Whether it means using multiple new technologies that all have different logins, or dealing with the added work of training site staff and patients on how to use the technology, or potentially having to provide tech support when patients have issues – sites need to know everything involved and who’s going to help keep all the parts moving. If they are a big part of that, they also need to know how they are going to be compensated.

Gregor: They have also made a lot of their own investments in technologies that they want to use. Sponsors need to consider how to integrate those with their own DCT systems so that a new system doesn’t add extra administrative burden and take away from clinical care. That’s going to be imperative for site adoption.

How do DCTs change the contracting process for sites, and how can sponsors address these concerns?

Kniola: It goes back to those early discussions with sites and understanding what role they play in the DCT. Sponsors may think that because patients aren’t coming in, it’s less work for the site, so they don’t have to pay them as much. But the site is still responsible for making sure that protocols are adhered to, maintaining oversight, and ensuring the data is entered. There is a lot of work involved that doesn’t touch the patient. If it requires more time to train on a technology or work with a home health nurse or train patients on a wearable, sponsors should expect that to be part of the budget as well.
Having a champion site that you work with who can help you understand the site-level implications of proposed DCT components can help you go into the contracting process understanding what the sites will have to do to get the work done and prepare you to reimburse accordingly. This will lead to more effective contract negotiations and prevent sites from feeling resentful. Because if they are resentful and feel unappreciated, they are not going to work as hard on your study.

What new questions should sponsors be asking as part of the site vetting process for DCTs?

Gregor: It breaks down to clinical and technical questions, and labor concerns. Many physicians and nurses have no problem embracing DCT technology and will require little education. But those who are less tech-savvy may be more nervous. In those cases, sponsors need to determine whether they can make the transition, and what change management efforts will make sites comfortable, so they are able to get what they need from an oversight perspective.

Kniola: It’s important to have those conversations early on instead of waiting until the investigator meeting to tell them you have 15 different fun new DCT gadgets that they will need to learn to use as part of the trial.

DCTs promise sponsors access to more diverse populations. What role do sites play in helping them meet those goals?

Gregor: DCTs provide the opportunity to not only expand a site’s geographic reach but to include trusted partners in the community, which could have a big impact on recruitment of underrepresented populations. To do that, sites need to partner with community leaders, advocacy groups, and local providers to offer education around clinical trials and to communicate that clinical trials can provide access to clinical care.

Kniola: This is so true. Diversity in clinical trials is not just about providing access. You can’t just open a trial site in a new community and expect diverse populations to feel lucky to be a part of the research. A lot of communities are uncomfortable with the idea of participating in clinical trials. These are barriers we have to cross, and we have to be willing to provide education and support to the patients if we want to capture truly informed data.

What advice would you offer sites about how to take advantage of the DCT movement?

Gregor: Sites need to embrace the change and work with sponsors to find new ways to do things that benefit everyone. The work they did during COVID proved they are capable. Now the challenge for sites is figuring out what they need to be successful going forward and how they can advocate for those needs with sponsors. It is important for sites to look at where they want to be in five years, not just where they are today.

Kniola: Again, without sites sponsors don’t have a study, so we need to keep involving them in the conversation. With DCTs, sites have a chance to speak up and let sponsors know not only how they are being impacted but what potential solutions will make DCTs a win-win. It will be important for both sponsors and sites to listen to each side, keep an open mind, and find common ground that is best for the study and the patients in order for the momentum that is being gained to keep going.

Stay tuned for part 2 of the conversation, where Kniola and Gregor discuss how sponsors can build patient-centricity into their DCT designs.