DIA 2023: Patient Feedback in Clinical Trial Design

This session at DIA opened with the question: how many of the attendees have asked for patient feedback on clinical trial design within the last 12 months? While the answers varied, the potential ways to get that patient feedback were listed by session chair, Valerie Powell, MS, Chief Patient Officer and EVP, Patient Experience at Corevitas. These include: long-term patient advisory boards, feedback from patient groups; 1:1 interview, clinical trial simulations, walk through the protocol, surveys, and co-design sessions.

DIA panel, "What Patients and Care Partners are Saying about Hybrid and Decentralized Trials, June 26, 2023. DIA 2023, Boston. Image Credit: © Lisa Henderson.

Panel members were asked to share their experiences on these feedback strategies. And while all agreed feedback was key, it would also depend on the person’s preference. For example, a herpes patient may not want to participate in a group situation, but a 1:1 interview would be more helpful for them.

Sarah Small, MS, Associate Director, Patient Centricity at Moderna, shared they have had more meaningful interactions around clinical trial simulations and get feedback on design from both patients and sites. “We have been surprised to hear about the tech we think patients would want, but they don’t. And then some technology is great, but it could be better. We just need to listen and ask them and, from there, truly meet their expectations and their needs.”

Working in rare liver disease, Julie Dietrich, MS, Vice President, Clinical Development at GENFIT, noted that many of their patients want more contact with their investigators, since they are experts at the top of their field.

For Clint Crowell, Head of Clinical Process Transformation, Beigene, patient panels are a great feedback tool. He shared that while one panel typically generates 18 to 20 insights, only 7 to 14 find their way into a design. “They discuss which component should be hybrid, which technology would be burdensome and to hear the discussions and debates, and the reasons why they want what they want. It’s very powerful.”

Concerns about seeking patient feedback

On the flip side, noted Crowell, while hearing what patients want, all of them can’t be incorporated. “It’s a tough decision,” he said.

The attendees were surveyed again on reasons patient feedback might be challenging, and that was one concern. The inability to be able to meet patient expectations for whatever reason.

Dietrich noted that shouldn’t be a barrier for discussion. She said that when educated on the reasons why a process, technology or other factor couldn’t be considered in a trial design, patients will understand the limitations.

Respect and empathy

For Small, she believes the key is to ensure that protocols are written in a flexible way so patients have the power to choose. She added, “Everyone is on their own DCT journey which may dictate what they want and don’t want. Some people don’t want people in their home. They come from different cultures, backgrounds, and experiences.” For example, one patient noted that she would feel that she would have to clean her house for a home health nurse. This, in turn, created a burden for that patient.

Steven Kowalski, a Patient Advocate who has ALS said also that a patient’s journey is different in the beginning than when it progresses. He remembers when he could get to the clinic, it was exciting for him because he and the site staff were learning from each other. Now, however, he says as his mobility challenges increase, he’s only involved in a decentralized trials.

Jill Abell, PhD, MPH, Executive Director Patient Experience and Immunology, Merck & Co, added there is a clear component of respect and not just with DCTs. She shared on one patient panel how patients feel about what the site staff or healthcare system thinks about them. Whether their condition, age or even their insurance status. Abell said, “It’s important not to judge people.”

For Myles, respect goes hand in hand with empathy. In a recent trial with a DTRA partner, a post-operative CV trial recruited very quickly, but patient drop out was also high. What they found out was that the help desk that patients contacted didn’t understand the disease burden. “So, it’s not just how to fix the tech, but the staff didn’t understand what they were going through. They need to offer that that empathetic perspective.”

Reference: What Patients and Care Partners are Saying about Hybrid and Decentralized Trials, June 26, 2023. DIA 2023, Boston.