Recruiting for Challenging Indications

Non-alcoholic steatohepatitis (NASH) is another challenging indication to recruit, because it’s asymptomatic in early stages. Even when symptoms arise, they tend to be vague and non-specific, resulting in delays to diagnosis. There is also significant competition for patients to participate in clinical trials.

Our recruitment strategy to address challenging NASH enrollment is to focus on patients with high risk factors and/or diagnosis. We access a large pool of patients with comorbidities such as obesity, Type 2 diabetes, or other cardiovascular disease risk factors, which are known to be at a greater risk for NASH. AES addresses NASH-specific identification and enrollment challenges with onsite FibroScan^® screening capabilities. Unlike other networks, our scanners are all linked via a single gateway allowing excellent quality control and oversight. Plus, the AES database includes 200,000 known non-alcoholic fatty liver disease (NAFLD)/NASH candidates, and one million likely candidates.

Inflammatory bowel disease (IBD) is another condition that’s difficult to recruit. Even if patients have sufficient symptoms to meet diagnostic criteria, they may not have discussed it with their doctors or be aware that their symptoms are severe enough to be considered a diagnosable condition. Patients need to be “in flare” to be eligible for a trial, making recruitment especially challenging.

AES has the ability to re-engage pre-qualified patients not “in flare” at time of pre-screening through our “MyColo” app and phone outreach. We also have access to gastroenterology patients through partner GI specialty practices. In AES surveys, patients repeatedly say that being seen by a specialist in their disease (e.g., for an upper endoscopy) is a motivating factor to join a clinical trial. In addition, our experience of recruiting more than 400 patients for seven IBD studies in the past five years means we know how to message IBD patients in the ways they prefer to engage.