Washington DC, August 20, 2020 – The Forum for Collaborative Research announced the publication of the manuscript, “Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility: Recommendations from the Multi-stakeholder Liver Forum” in Gastroenterology.
“Patients with NASH cirrhosis have an urgent need for new therapies,” said Veronica Miller, PhD, Executive Director of the Forum for Collaborative Research. “But clinical trials are challenged by the complicated nature of the disease and difficulty with identifying this patient population for enrollment.”
The manuscript is the result of extensive discussion and consensus development within the Liver Forum’s NASH Cirrhosis Working Group which includes experts from academia, industry, and regulatory agencies, and is led by Naga Chalasani, MD, Indiana University, and Arun Sanyal, MD, Virginia Commonwealth University.
“NASH is a multisystemic disease with multiple comorbidities, such as type 2 diabetes and obesity, playing a role in its process,” said Mazen Noureddin, MD, MHSc, Director, Fatty Liver Program at Cedars-Sinai, and leading author. “Once patients with NASH develop cirrhosis, their identification may be made via the assessment of histological features of NASH and the associated cirrhosis. Nevertheless, some or all of the histological features of NASH may disappear leaving cirrhosis without a distinct etiology.”
“Fortunately, the associated comorbidities can help us attribute the underlying cirrhosis to NASH,” he said. “This consensus document unifies the effort for such definitions and will lead to conducting NASH cirrhosis clinical trials under the same and highest standards.”
The manuscript addresses this barrier by recommending appropriate case definitions for determining the likelihood that NASH is ‘definitely’, ‘probably’ or ‘possibly’ the etiology of a patient’s cirrhosis. These definitions will be a valuable resource for those involved in the design and conduct of clinical trials for patients with NASH cirrhosis.
The Liver Forum is a project of the Forum for Collaborative Research. The article is available online at: https://authors.elsevier.com/c/1bbMP3mEmVHES.
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About the Forum for Collaborative Research
Founded in 1997, The Forum for Collaborative Research at the University of California Berkeley School of Public Health is a public/private partnership with a mission to catalyze clinical development and improve global health by facilitating research, informing policy, and advancing regulatory science. The Forum’s three-pronged approach (practice, research, education) accelerates safe drug development by increasing clarity, cooperation and innovation, while maintaining standards of evidence. Forum members work in clinical practice, research, academia, industry, regulatory authorities, and patient advocacy. Using proven models for stakeholder engagement they enhance clinical trial efficiency, support fair participation, and expand access programs. Current projects focus on cytomegalovirus (CMV), viral hepatitis B (HBV), human immunodeficiency virus (HIV), nonalcoholic fatty liver disease (NAFLD)/ nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and rare diseases.
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