Washington DC, April 27, 2020 – The Forum for Collaborative Research announced the acceptance and online publication of the manuscript, “Standardization of Diet and Exercise in Clinical Trials of NAFLD-NASH: Recommendations from the Liver Forum” in Journal of Hepatology.
“Lifestyle modification is the foundation of treatment recommendations for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis,” said Veronica Miller, PhD, Executive Director of the Forum for Collaborative Research. “But clinical trial design is impeded by the absence of consistent approaches and documentation of lifestyle changes, and understanding the potential influence on trial outcomes.”
The manuscript is the product of the Liver Forum Standard of Care Lifestyle Working Group, which was led by Manal Abdelmalek, MD, MPH, Duke University School of Medicine and Sven Francque, MD, PhD, Department of Gastroenterology and Hepatology, University of Antwerp. “Standardizing approaches to lifestyle recommendations in clinical trials for NAFLD-NASH is essential to lend better insight into the confounding factors relating to diet and exercise, including the associated geographic and cultural differences which contribute to placebo response rates,” said Abdelmalek. “Standardized approaches will facilitate the ability of investigators, industry sponsors, and regulatory authorities to better interpret outcomes of clinical trials in a complex disease and associated emerging therapeutic landscape.”
The publication summarizes clinical data, identifies barriers, defines assessments of lifestyle changes, and proposes approaches to understanding the influence of diet and exercise on NASH treatment in the context of pharmacologic interventions.
“It is our goal to provide a resource that lays out the considerations for better understanding the influence and impact of lifestyle modification on clinical outcomes in trials of NAFLD-NASH,” said lead author Oliver Glass, PhD, Director of Research, Duke Health and Wellness.
The Liver Forum is a project of the Forum for Collaborative Research. The article is available online at: https://www.journal-of-hepatology.eu/article/S0168-8278(20)30274-9/fulltext
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About the Forum for Collaborative Research
Founded in 1997, The Forum for Collaborative Research at the UC 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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