Synexus is part of Accelerated Enrollment Solutions (AES), a business unit of the contract research organization (CRO) PPD.
In collaboration with Acurian – which provides patient enrollment and retention solutions – Synexus yesterday introduced a solution for enrolling patients in clinical studies for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).
The new solution draws on Acurian’s proprietary database of 100m people, which includes thousands of confirmed/diagnosed NAFLD patients, as well as patients at high risk for NAFLD/NASH who potentially can be diagnosed with a screening biopsy, said Roger Smith, senior vice president and general manager of PPD’s AES business unit.
“We also have a large pool of patients with co-morbidities (diabetes, obesity, high blood pressure, high cholesterol) known to occur together with NAFLD/NASH,” he told us.
“More than 70,000 respondents have self-reported fatty liver disease in Acurian’s pre-screening for related conditions, providing a ready-made audience for our targeted messaging and outreach campaigns.”
NAFLD is underdiagnosed due to its “silent” nature, said Smith, explaining that the disease often presents with no clinically significant symptoms, which delays timely diagnosis and treatment.
“Nonalcoholic steatohepatitis (NASH) diagnosis rates are even lower, and it is often only detected as an incidental finding while evaluating the patient for another medical condition, or when liver damage already has progressed,” he added.
Additionally, Smith said many primary care physicians lack direct experience in NASH and the means with which to diagnose patients. “Moreover, a definitive diagnosis of NASH has traditionally required an invasive liver biopsy,” he explained.
“NASH clinical trials often seek to enroll patients who already have such a diagnosis, or who can be diagnosed at the time of screening, which poses a number of challenges,” Smith added. “The lack of prior diagnosis via liver biopsy limits the pool of applicable patients.”
Compounding on these challenges, Smith said the current NAFLD/NASH clinical research arena is crowded, “with many companies and compounds competing for a small number of available sites and patients.”