Survey reveals patients’ thoughts on trial participation

The patient recruitment specialists at SubjectWell recently surveyed 561 at-risk patients (aged 50 and older) with Type 2 diabetes, in order to gauge their attitudes toward participation in trials pertaining to nonalcoholic steatohepatitis (NASH) and fatty liver disease(FLD). The group included 74 individuals diagnosed with NASH and FLD.

According to researchers, the survey indicated patients with either NAFLD or NASH were 21% more likely to be willing to take part in a study for their diagnosed condition than an undiagnosed patient at a high risk of developing those conditions. Additionally, because the ailments disproportionately affect Hispanic communities, the survey examined how ethnicity might influence research participation.

• 88% of Hispanics are likely to report helping others suffering from liver disease and helping to advance science as motivators for participating in clinical research (compared to 79% of non-Hispanics).
• 78% of Hispanics indicate obtaining education about treatment is a motivator for a participation (compared to 70% of non-Hispanics).

Outsourcing-Pharma (OSP) recently discussed the survey with SubjectWell CEO Ivor Clarke (IC) and what it might reveal about potential patient participant motivations.

OSP: Can you share why SubjectWell decided to check in with patients on their attitudes toward clinical trials, and why the focus on liver disease patients?​

IC: By understanding patient’s attitudes toward clinical trials, which vary by race, ethnicity, gender and age, we highlight the challenges and motivations to trial participation. Understanding the variance in patient motivations can improve the industry’s patient recruitment methods and messaging and better serve diverse patient needs. 

Looking specifically at this latest survey, we recognize the devastating statistics regarding the rise of liver diseases across the US. Sponsors and CROs have a difficult time recruiting FLD and NASH patients, a progressive disease that is often asymptomatic until late stage.

SubjectWell has successfully recruited for 31 NASH trials over the last year and a half with 5 trials currently enrolling in our marketplace. Additionally, we are aware of 41 NASH studies either in-design or enrolling that we thought would benefit from insights into this patient populations’ motivations and attitudes toward clinical research participation.

OSP: Do liver patients face unique challenges when it comes to trial participation, compared to patients dealing with other conditions?​

IC: Liver biopsy is the current diagnosis standard for NASH and the indication standard for most NASH clinical trials. A liver biopsy is an invasive, expensive procedure where a small portion of the liver is removed for testing.

Given the possibility of future negative symptoms or health outcomes, there are enormous advantages to finding FLD and NASH patients early in the disease progression and matching patients with NASH trials.

OSP: Your survey reveals Hispanic patients are more likely to participate than non-Hispanic; can you share why the difference in motivation?​

IC: Across the US, FLD and NASH disproportionately affect Hispanic communities, so we looked closely at the responses from this patient population. Our survey found only a small difference in Hispanic patients compared to non-Hispanic patients' interest in clinical trial participation (68% and 63%, respectively).

That said, we did find that more Hispanic patients reported motivation to participate in a clinical trial to help others who are suffering, to help advance science and to obtain education about treatment.

OSP: Can you share if patients with a more dire outlook were more or less likely to participate in trials than patients with a brighter outlook?​

IC: The survey did not look at predicted patient outcomes. However, we did see a significant jump in reported interest in clinical trial participation from patients with diagnosed liver disease compared to those patients at-risk for liver disease.

Patients with either FLD or NASH were 21% more likely to report a willingness to participate in a trial for their diagnosed condition than the undiagnosed patient’s likelihood of participating in a trial they were at high-risk of developing (69% and 57%, respectively).

OSP: What do you expect or hope pharmaceutical companies and their research partners might gain from the findings, and how do you think the findings might inform their work in the future?​

IC: SubjectWell’s robust access to both patients at-risk and diagnosed with liver disease provided a unique opportunity to compare populations. Overall, we found that all patients responded similarly when considering clinical trial participation, with no significant differences in motivations.

While no silver bullet was discovered, the survey results suggest that both patients at-risk and diagnosed with liver disease are similarly motivated by clinical trial participation and would benefit from the industry trends toward patient-centric policies and decentralized trial design.

OSP: Is there anything you’d like to add not touched upon in the above questions?​

IC: SubjectWell has fielded numerous surveys over the past year, tapping into our growing and continuously updated patient pool.  We’ve uncovered invaluable insights, in part due to the diversity of our patient registry, as nearly 44% of our patients identify as Asian, Black, Latino or Native American.

In early November, we found differences in COVID-19 concerns varied by race. SubjectWell is on the forefront of addressing the industry’s lack of diversity in clinical trials and is helping to ensure that individuals from diverse backgrounds have equal access to ongoing clinical research.