Let’s Not Forget the Patient Perspective in Clinical Trials

Many sponsors have discussed the challenges of operating clinical trials during the pandemic, but there hasn’t been much discussion around the patient experience, and how patient feedback can help sponsors better design their studies to meet patients’ evolving needs. In this interview, Valerie Powell, Vice President of Research Services at HealthiVibe, discusses her experience with obtaining patient insights and helping her clients apply them to trial design and conduct in a pandemic.

Moe Alsumidaie: What challenges have you seen Sponsors and sites face as they continue to recruit and retain patients in global clinical trials during this pandemic?

Valerie Powell

Valerie Powell: The challenges fall into at least three categories. First of all, many study subjects are fearful and unwilling to attend in-person trial visits, so they either aren’t enrolling or are dropping out. Secondly, patients and caregivers are focused on daily living issues during the pandemic, not on medical care, including trial participation. Lastly, site staff burden has increased sharply. Hospital-based sites are dealing with COVID surges, with some PIs being called into service to help and study staff adapting to changes in their work environments, working from home or juggling study requirements with cumbersome on-site pandemic precautions. The studies themselves are taxing staff, as they deal with delays, cancellations, and protocol changes to accommodate the shift to virtual visits, and the significant burden related to remote monitoring visits.

MA: How has patient willingness to enroll in clinical trials changed? What are you hearing from patients now?

VP: Clinical trial participation can be scary—and now, we have the added fears of contracting the virus at site visits and receiving an experimental treatment during a pandemic. While this fear can decrease willingness to participate, changes to trial designs—telemedicine and home health visits—can make participation more attractive if done in ways that resonate with patients and caregivers. A shift that I expect could have an even more significant impact is the increased familiarity with clinical trials (due to the COVID-19 vaccine trials being in the news). This familiarity can breed acceptance.

First, patients are hearing and learning more about trials. Now laypeople who have never considered a trial know more about the trial process, which builds comfort and helps break down misconceptions. Second, because of the worldwide focus on the need for a vaccine, the public sees the value of clinical trials in a new and real way. Finally, the emphasis on involving diverse populations in the vaccine trials could help break down some barriers in enrolling diverse populations in our trials. I’m hopeful that we will see prolonged support of clinical trials and reduced stigma around participation – it could be a small silver lining to this pandemic experience.

MA: What are patients requesting to help make them feel safe participating in clinical trials during these challenging times?

VP: To feel safe and be willing to participate, what patients want is not always what the sponsors expect. It varies by therapeutic area, the severity of the disease, demographics, and other factors. For some conditions, patients are very enthusiastic about home visits and telemedicine; in other conditions, such as severe chronic illnesses and cancers, we see patients asking for reassurance that they’ll still see the study doctor regularly – that’s what will make them feel safe, despite the pandemic. Some patient populations are also very enthusiastic about using devices – vital sign monitors, sleep monitors, and adherence apps, to name a few – while others are resistant due to discomfort with the technology or privacy concerns. Ultimately, each trial and each patient population are different. Designing a trial and testing technologies with the targeted patients remains the best way to ensure you’ll have robust enrollment and retain trial subjects.

MA: How have sponsors and sites pivoted to meet the needs of patients during the COVID pandemic?

VP: As mentioned, many sponsors have shifted to home health nurse visits and the use of study-support technologies. The pandemic has also caused us to finally take a close look at the burden of study participation—frequent and extended study visits, multiple procedures—and find ways to scale back study requirements to focus on need-to-know data, not nice-to-know data. Many sites have taken a hands-on approach to explain study requirements, reassuring patients, and genuinely coaching study subjects throughout the process. The most successful sponsors have engaged both sites and patients to learn what will work for them before implementing any changes.

MA: What still needs to be done to ensure successful, patient-centric clinical trials during COVID times and beyond?

VP: Engaging with patients to co-design clinical trials is still seen as an optional activity by most sponsors. Even sponsors who engage patients regularly often do so when it’s too late and a protocol cannot be changed. I’m hopeful the challenges of operating studies during the pandemic have begun to cause a shift—that sponsors see the benefit of engaging patients early and often. Some of our clients give patients and caregivers a seat at the table from very early in the development process, before portfolio entry, to identify meaningful endpoints and effectively shape clinical development programs. For those of us who’ve dedicated our careers to this work, that’s a very good sign. It is true patient engagement.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.