Understanding Key Challenges
The first step to successful NASH trial enrollment is acknowledging the many challenges we face. We know we need significant patient volume in order to meet the high enrollment numbers required of the many trials enrolling or not-yet enrolling. Based on rate of diagnosis and historical information about the number of people willing to participate in clinical research, the pool of potential NASH research patients is about 3,000 in the US. Our research indicates we will need to randomize 30,000 NASH patients to accommodate Phase II and Phase III trials over the next 5 years—that’s 10 times more than we currently have.
We know many of the patients with NASH have never even heard of the condition, let alone have a diagnosis, so disease education must be incorporated into campaign messaging. We know that reaching and motivating this patient population will be difficult because of the previous two challenges—a dense competitive landscape means your trial must be differentiated in materials and outreach, and reaching a condition-naïve population will require precise messaging. This means we will have to prioritize gathering wide-ranging patient insights, and develop multiple target patient personas based on these cohorts and insights. And we know that, based on prevalence data, any successful campaign must incorporate robust Diversity & Inclusion initiatives.
Developing Patient Personas for Outreach
Building a deeply profound affinity with the target patient is key to understanding their lived experience and motivating them to enroll in a clinical trial.
What we know about NASH and NAFLD patients is that there is no universal patient experience or diagnosis pathway. We have to keep that in mind when developing a patient recruitment strategy. We know that those at highest risk of developing NASH are over 50, Hispanic or Latino, female, and have comorbidities of diabetes, hypertension, or elevated liver enzymes. We will use this information when developing outreach. We will use this incidence/prevalence data combined with our patient insights to develop personas for our recruitment campaigns. We recommend developing campaigns that target multiple personas since this patient population is so diverse. For NASH trials, we would likely develop 3 unique personas—an African American woman, Caucasian male, and LatinX woman. Each persona will receive its own key messages and imagery, to make sure that the content is relevant and motivating to each of these important audiences. Our outreach campaigns need to resonate with how each unique patient sees themselves and their health, in order to authentically connect and motivate each target patient to take action.
Prioritizing Diversity and Inclusion
Our research indicated the LatinX community showed increased interest in NASH clinical research—this is fortunate, since they are also at an increased risk of developing the disease. This increased interest coupled with the increased prevalence underscores the need for prioritization of a diversity and inclusion strategy to be incorporated into the recruitment campaign. Engaging patients at a hyper-local level via community events is something patient advocates can and should do to educate and connect with patients both before and after diagnosis. This kind of advocacy and D&I effort will ensure that recruitment campaigns are executed in such a way that they can be most effective.
Recruiting patients for NASH trials will not be easy—if there is any theme in what we have learned and the content we have consistently shared, it’s that. But it’s also this: it can be done if we are thoughtful and respectful of patients living with NASH, and if we prioritize their voices in the clinical trial communications we produce.