Recruiting patients for clinical trials is a challenge, no matter the therapeutic area, no matter the therapeutic area, indication, or the protocol. Finding patients (and sometimes physicians) who understand the potential benefits, accept the potential risks, and are willing to commit their time and energy to a study schedule can be difficult even under the best circumstances.
But what if your target audience hasn’t been diagnosed with the condition you’re recruiting for? What if they’ve never heard of the condition to begin with? What if even their physicians are unfamiliar with the disease?
This is the challenge we face when reaching and enrolling patients for NAFLD and NASH clinical trials. It means we have to rethink many of the strategies we turn to for recruitment. Digital outreach like paid search becomes more difficult if patients aren’t searching for information on the condition because they’ve never heard of it. Paid social targeting becomes broader (and therefore less precise) because patients aren’t joining groups specific to managing their condition. On the whole, our target audience has to expand to include patients diagnosed with one of many common comorbidities. Even those comorbidities are challenging in some ways: when does a patient consider themselves overweight versus obese? Are patients likely to know their BMI? What if these parameters are part of the I/E criteria for a given protocol? The challenges abound.
So, what can we do? How do we find and motivate a difficult-to-reach patient population?
Continuum Clinical has seen similar challenges before. In one such example, we needed to enroll condition-naïve patients with multiple comorbidities for a protocol that included an anticipated high screen-fail rate. We can look to this study, which we enrolled successfully, for clues on how to best approach NAFLD and NASH trial enrollment.
Only a deep understanding of the patient population’s attitudes and motivations gives us the information we need to develop effective materials and campaigns.
Success begins with insights and education. Gathering patient insights is foundational to most of our clinical enrollment programs, but when our target population is this broad, it becomes even more important. Continuum Clinical has already conducted large-scale patient insights research into the patient population at-risk for NAFLD/NASH. These actionable insights will help us to find common attitudes and behaviors among our audiences and allow us to develop umbrella messaging that can remain cohesive throughout the program. Then, we can refine our secondary messages for particular tactics, ensuring they are more specific to the smaller target audience.
Incorporating disease education into our messaging was extremely important in the trial mentioned above and will be a primary component of any NAFLD/NASH outreach. The messaging hierarchy between education and inspiration must be balanced and nuanced. Only a deep understanding of the patient population’s attitudes and motivations gives us the information we need to develop effective materials and campaigns.
Since these difficult-to-reach patients are also condition-naïve, prioritizing physician engagement and education is likely one of the primary resources for finding qualified patients. This requires a deep physician network that can be activated and scaled to match the enrollment goals of the sponsor. Patients are less likely to engage with clinical research when they haven’t been diagnosed with their condition for long, both because of the shock of diagnosis and because they have not yet had the opportunity to research other treatment options. When clinical research is presented by their physician, patients are more comfortable with it as an option. Patients referred from physicians also have historically lower screen failure rates. In the study referenced above, patients from our physician referral network had a 33% lower screen failure rate than patients referred from traditional outreach.
The last piece of this recruitment challenge is at the site level. Because patients are undiagnosed and/or condition-naïve, site staff must be prepared for higher screen failure rates than they may be used to processing. They also may not be able to easily identify potential patients within their databases because of low diagnosis rates. Preparing staff for the increased amount of screening time and prep work that will go into enrolling these trials will ensure they are better able to prioritize enrollment among their other tasks.
Enrolling NAFLD/NASH clinical trials is a challenge on many levels. But these are not wholly unique challenges. Smart strategies combined with patient insights and the institutional knowledge of how to overcome similar recruitment obstacles make trial enrollment achievable. We have seen the strategies outlined here work time and time again with other difficult-to-reach patient populations.
