Catherine Gregor
Chief Clinical Trial Officer
Florence Healthcare

Cari Kniola
Senior Director, Corporate Strategy
Aperio Clinical Outcomes

October 18, 2022

Sponsors need more patients to participate in clinical research, and decentralized clinical trials provide an important strategy to make that happen. Decentralized Clinical Trials overcome many of the barriers patients face when they join a trial, and they offer easier access to more diverse populations. But that doesn’t mean sponsors should expect patients to just start knocking on their doors.

Most people aren’t even aware that clinical trials are an option for their care or that telehealth, home health services, and other Decentralized Clinical Trial elements can be part of that experience. “The industry talks a lot about wanting patients to be more engaged in clinical trials, but for the majority of patients, they have no idea what that means,” says Cari Kniola, Aperio’s senior director of corporate strategy.

“If sponsors and sites want to use Decentralized Clinical Trials to attract more participants, they need to be more strategic in how they engage, screen and support patients throughout the trial experience,” she says. “And with FDA’s recent guidance on Clinical Trial Diversity, as well as their guidance on clinical trial Diversity Plans, the use of Decentralized Clinical Trial (DCT) components to open the door to more diversity makes getting the patient experience right even more important.”

Kniola recently participated in a roundtable interview with Catherine Gregor, Chief Clinical Trial Officer for Florence, the industry leader in remote connectivity in clinical research, to talk about how sponsors can make their clinical trials more patient-centric.

Do you think patients need to be more involved in clinical trial planning and protocol design?

Gregor: I do. The traditional narrative is the sponsor talking to the doctor about the protocols, then the doctor telling the patient what is going to happen. But what if we reversed that conversation? What if we start with the patient saying, ‘this is what I want to do,’ and the site shares those insights with the sponsor?

Imagine what the protocol development and recruitment process would look like from that perspective. Instead of trying to convince a bunch of people that they should feel lucky to be a part of the clinical trial you designed, start with what they need, and build from there.

Kniola: Absolutely. It can help sponsors understand what patients actually want, instead of making assumptions. You are not being patient-centric if you force them to adopt a way of doing things. For example, some patients may not be comfortable with a stranger coming to their house to do an exam and would prefer to go to the clinic. Patient-centricity is about giving them options while still getting what you need out of the clinical trial.

How can sponsors enable that kind of flexibility while still adhering to the goals of the trial?

Kniola: Flexibility can be a challenge for sponsors, who are used to rigidity in clinical research. But planning for some flexibility, like giving patients the option of using their own device for patient diaries and ePROs, can make it more patient-centric and engaging for everyone.

They also need to be sure the technology meets the needs of all users. It can’t just be what is new and flashy and sounds cool. It has to fit the population. If you expect an Alzheimer’s patient to use a complicated wearable or log into an ePro on an unfamiliar tablet, it will backfire horribly.

What can sponsors and sites do to engage the patient community?

Gregor: We need to speak directly to the community about clinical research and share opportunities versus waiting for a physician to introduce the idea. Physicians reinforce the value of clinical research, but sponsors and sites also have to start those conversations. It’s something that we haven’t been good at in the past.

Kniola: Sponsors and sites should leverage technology to educate patients and their families. For example, providing videos that explain what’s involved in clinical research so patients and their caregivers feel informed before they sign eConsent forms. Because trials don’t affect just the patients. They impact caregivers and family members who want to know what their loved ones are getting involved in. Answering their questions as part of the outreach process can be hugely beneficial.

This added education isn’t free. But at some point, we’re going to have to realize that the cost of taking extra steps to help patients feel more comfortable is going to be far outweighed by the benefits of having participants who are truly engaged in the study.

What messages do you think are important to share with the patient population about DCTs?

Gregor: A lot of patients don’t understand what DCTs are, because it’s not a part of their world. So it is important to talk about the reduced burden of commitment, and how the clinical trial is happening in their own communities and healthcare centers. It can help change the perspective of clinical research from something that is only done in the ivory tower of an academic medical center to something that happens in their own community.

How can sponsors and sites address the lack of trust patients have for clinical research?

Kniola: Part of the solution is building relationships in the patient community, so it is not just a bunch of people in lab coats telling them what to do. For example, rare diseases often have support groups where they talk about research that they were involved with. In these settings, patients are educating each other. Sponsors can also invite past participants to speak at a conference about their experiences, instead of having the site investigator do it. That kind of peer-to-peer interaction can be a valuable way to communicate about clinical research participation.

Gregor: We need to encourage physicians to talk about it as part of their day-to-day patient interactions. When I had a community practice, we posted signs that said ‘ask us about clinical trials’ because I wanted to increase the awareness with our patients that it was something we offered. Sponsors can also create informational materials to hand out at community events and talk to people about their fears and the role they play. If you want patients to consider being a part of a trial, you need to make a human connection and make them feel like a valuable part of the process.

Check out part 1 of the conversation, where Kniola and Gregor discuss how sponsors can better meet the needs of sites in the Decentralized Clinical Trial journey.