BOSTON--(BUSINESS WIRE)--Acurian Inc., a leading full-service provider of global patient enrollment and retention solutions, and Synexus, the leading global network of dedicated research sites, have launched a comprehensive solution for enrolling patients in clinical studies for nonalcoholic fatty liver disease (NAFLD) and its advanced form, nonalcoholic steatohepatitis (NASH). This integrated new offering, introduced at the second annual NASH Summit in Boston this week, leverages the current success of Synexus in NASH studies.
Acurian and Synexus, as part of Accelerated Enrollment Solutions (AES), a business unit of PPD, the global contract research organization (CRO), will combine efforts to enable trial sponsors to find, qualify and enroll NAFLD and NASH patients more effectively and efficiently. Acurian’s proprietary database of 100 million households 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.
The database also contains a large pool of patients with co-morbidities (diabetes, obesity, high blood pressure or high cholesterol) known to occur together with NAFLD/NASH. 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 targeted messaging and marketing outreach campaigns.
“Acurian and Synexus have proven track records enrolling patients in difficult-to-recruit disease states through best-in-class, multi-channel, direct-to-patient identification and engagement capabilities, coupled with an extensive site network,” said Roger Smith, senior vice president and general manager of AES.
Qualified subjects may be referred to Synexus sites for non-invasive screening and possible trial enrollment. Whether the patient goes to a Synexus site initially for less invasive liver screening or is referred to a client’s study site (with medical records and pre-screening results), Acurian can efficiently manage the entire NASH enrollment workflow.
“With this new enrollment solution, we can give clients greater access to a wider NAFLD/NASH patient population, and a unique approach to finding these patients,” said Dawie Wessels, chief medical officer of Synexus.
Based on current statistics, NAFLD and NASH are highly prevalent today, with 20-40 percent of adults suffering from NAFLD, predominantly in the Western world, and 11 million U.S. adults who face NASH.
Both, however, are characterized by a low diagnosis rate and a lack of approved therapies. The silent nature of NAFLD, which often presents with no clinically significant symptoms, delays diagnosis and treatment. NASH diagnosis rates are even lower, often detected incidentally while evaluating for another condition or when liver damage has progressed.
A definitive diagnosis of NASH traditionally has required an invasive liver biopsy. NASH clinical trials often seek to enroll patients who already have been diagnosed, or who can be diagnosed at screening, which poses significant challenges to sponsors because the lack of prior diagnosis via liver biopsy limits the applicable patient pool. But a presumed NAFLD or NASH diagnosis can be made without a biopsy. Such a diagnosis may be based on imaging (ultrasound or non-invasive diagnostic techniques), labs (liver function tests) and patient history.
For more information on how to target undiagnosed NASH patients, request a copy of the e-book, “Hiding in Plain Sight: Finding the NASH Patient,” by emailing NASH@ppdAES.com.
About Accelerated Enrollment Solutions
Accelerated Enrollment Solutions is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrollment solutions by combining offerings of industry leaders Synexus, Acurian and Optimal Research. These solutions are available as discrete services or integrated to provide a cohesive and highly differentiated trial acceleration strategy for insourced or outsourced clinical studies, all under performance-based commercial terms. The array of integrated solutions includes PatientAdvantage, PPD’s global clinical development services optimized with Acurian and Synexus enrollment capabilities. Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network. When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time.