Washington DC, May 23, 2019 – The Forum for Collaborative Research announced publication of a new article, "Defining Improvement in Nonalcoholic Steatohepatitis for Treatment Trial Endpoints: Recommendations from the Liver Forum," in the peer-reviewed journal, HEPATOLOGY.
Nonalcoholic steatohepatitis (NASH) is characterized by inflammation and the accumulation of excess fat in the liver, which may lead to cirrhosis, liver cancer, and liver failure. Development of therapies is challenging in part due to a lack of non-invasive efficacy markers.
"This paper is a review of where the field is now in our understanding of blood tests, imaging tests and functional testing of the liver and how these measure change with treatments of NASH," said Brent A. Neuschwander-Tetri, MD, Director, Division of Gastroenterology and Hepatology and Professor of Internal Medicine at Saint Louis University. "It provides a foundation for future research on the development of biomarkers of improvement or progression and I expect that we will be seeing many tests being evaluated and hopefully validated in the context of current treatment trials."
"Drug approval requires evidence of clinically meaningful benefit," said Veronica Miller, PhD, Executive Director of the Forum for Collaborative Research. "This means demonstrating improvement in how patients feel, function, or survive. For slow-progressing diseases such as NASH, we urgently need validated biomarkers that predict clinical benefit."
The authors were Amanda Cheung, MD; Brent A. Neuschwander-Tetri, MD; David E. Kleiner, MD, PhD; Elmer Schabel, MD; Mary Rinella, MD; Stephen Harrison, MD; Vlad Ratziu, MD, PhD; Arun J. Sanyal, MD; Rohit Loomba, MD, MHSc; Sophie Jeannin Megnien, MD; Richard Torstenson, MScPharm, PhD; and Veronica Miller, PhD; on behalf of the Liver Forum Case Definitions Working Group.
"This paper is the result of a large multi-stakeholder working group of the Liver Forum," said Katherine Barradas, MPH, Senior Research Associate with the Forum for Collaborative Research. "We are excited for these recommendations to be published and available for those involved in the design of NASH trials."
The Liver Forum is a project of the Forum for Collaborative Research. The article can be found online at: https://doi.org/10.1002/hep.30672.
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, decreasing uncertainty, removing redundancy, and lowering risk. 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.
Media Contact
Vincent Keane, Communications Management
The Forum for Collaborative Research
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
www.forumresearch.org
Nonalcoholic steatohepatitis (NASH) is characterized by inflammation and the accumulation of excess fat in the liver, which may lead to cirrhosis, liver cancer, and liver failure. Development of therapies is challenging in part due to a lack of non-invasive efficacy markers.
"This paper is a review of where the field is now in our understanding of blood tests, imaging tests and functional testing of the liver and how these measure change with treatments of NASH," said Brent A. Neuschwander-Tetri, MD, Director, Division of Gastroenterology and Hepatology and Professor of Internal Medicine at Saint Louis University. "It provides a foundation for future research on the development of biomarkers of improvement or progression and I expect that we will be seeing many tests being evaluated and hopefully validated in the context of current treatment trials."
"Drug approval requires evidence of clinically meaningful benefit," said Veronica Miller, PhD, Executive Director of the Forum for Collaborative Research. "This means demonstrating improvement in how patients feel, function, or survive. For slow-progressing diseases such as NASH, we urgently need validated biomarkers that predict clinical benefit."
The authors were Amanda Cheung, MD; Brent A. Neuschwander-Tetri, MD; David E. Kleiner, MD, PhD; Elmer Schabel, MD; Mary Rinella, MD; Stephen Harrison, MD; Vlad Ratziu, MD, PhD; Arun J. Sanyal, MD; Rohit Loomba, MD, MHSc; Sophie Jeannin Megnien, MD; Richard Torstenson, MScPharm, PhD; and Veronica Miller, PhD; on behalf of the Liver Forum Case Definitions Working Group.
"This paper is the result of a large multi-stakeholder working group of the Liver Forum," said Katherine Barradas, MPH, Senior Research Associate with the Forum for Collaborative Research. "We are excited for these recommendations to be published and available for those involved in the design of NASH trials."
The Liver Forum is a project of the Forum for Collaborative Research. The article can be found online at: https://doi.org/10.1002/hep.30672.
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About the Forum for Collaborative ResearchFounded 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, decreasing uncertainty, removing redundancy, and lowering risk. 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.
Media Contact
Vincent Keane, Communications Management
The Forum for Collaborative Research
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
www.forumresearch.org