coreNASH: Developing a Core Outcome Set for NASH Clinical Research

May 31, 2018

Green Park Collaborative, The Forum for Collaborative Research, and the Obesity Action Coalition (OAC) Launch coreNASH to Develop Consensus on Critical Outcomes in Non-Alcoholic Steatohepatitis (NASH) Clinical Research

Baltimore, MD (May 31, 2018) – The Green Park Collaborative (GPC), a major initiative of the Center for Medical Technology Policy (CMTP), is partnering with The Forum for Collaborative Research and the Obesity Action Coalition (OAC), to develop a core set of outcomes for non-alcoholic steatohepatitis (NASH). This initiative, coreNASH, will be conducted as a collaboration involving a multi-stakeholder team, including NASH patients, clinicians, payers, health technology assessment groups, regulators, life sciences companies and others, who will help establish a consistent and stakeholder-relevant baseline for evaluation of NASH therapies.

NASH is a serious chronic liver disease estimated to affect more than 15 million adults in the United States, and which can progress to cirrhosis, liver failure, cancer, and death. There are currently no approved treatments for NASH; however, there are many compounds currently under development, and a large number of clinical trials are underway.1  As a new generation of treatments are being developed, key issues regarding drug development are raised: Which study outcomes are most important to include in the assessment of the comparative effectiveness and value of these new treatments? Which aspects of the patient experience are relevant to consider? What outcomes are most relevant to regulators, payers, HTA groups and guideline developers?

To address these issues, coreNASH will develop a core set of outcomes to be used in the design of pivotal clinical studies of new treatments for NASH, and thus be available consistently for regulatory, market access, and care decision-making. The project will utilize a modified Delphi process to convene a multi-stakeholder group of experts and other key stakeholders to develop consensus around these outcomes. 

“This model of multi-stakeholder engagement, conducted in close partnership with a patient advocacy organization, has proven to be a successful approach to the timely development of core outcomes for inclusion in pivotal trials,” said Sean Tunis, President and CEO of CMTP. “We are excited to have the opportunity to apply this approach to develop a core outcome set for clinical studies of emerging therapies for NASH.”

Dr. Veronica Miller, Executive Director of the Forum for Collaborative Research and The Liver Forum, commented on the significance of this project, noting that “As more and more companies enter the NASH drug development field, and trials progress further in the drug development pipeline, this initiative is well-situated to have a major impact on the design and conduct of clinical trials. We believe that the Liver Forum’s focus on regulatory science, and GPC’s focus on reimbursement science are very complementary and synergistic, and we are thrilled to partner with GPC and OAC on this important endeavor.”

“As the link between NASH and obesity becomes clearer each day, there is a significant need to explore science-based treatment to help individuals impacted by this disease. The OAC finds tremendous value in being part of coreNASH and the development of set outcomes for treatment development,” said Joe Nadglowski, OAC President and CEO.

The coreNASH team will publish a white paper and accompanying peer reviewed article providing recommendations for patient-important outcomes for inclusion in clinical studies. These results are expected in mid-2019. Use of these outcomes will help assure relevant outcomes are available to patients and clinicians for better treatment decisions, to payers for better policy decisions, and help companies have better predictability in how their studies will be assessed.

About the Green Park Collaborative
The Green Park Collaborative (GPC) is a major initiative of the Center for Medical Technology Policy, an independent 501(c)(3) non-profit organization dedicated to improving the quality, relevance, and efficiency of clinical research. GPC is a multi-stakeholder forum for developing condition- and technology-specific study design recommendations to guide the creation of evidence needed to inform both clinical and payment decisions.

About The Liver Forum
The Liver Forum is an initiative of the Forum for Collaborative Research, part of the University of California, Berkeley School of Public Health. The Liver Forum was launched in 2014 in response to the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease meeting sponsored in 2013 by the U.S. Food and Drug Administration and the American Association for the Study of Liver Disease.

About the Obesity Action Coalition
The Obesity Action Coalition (OAC) is a more than 58,000 member-strong 501(c)(3) National non-profit organization dedicated to giving a voice to the individual affected by the disease of obesity and helping individuals along their journey toward better health through education, advocacy and support. Our core focuses are to raise awareness and improve access to the prevention and treatment of obesity, provide evidence-based education on obesity and its treatments, fight to eliminate weight bias and discrimination, elevate the conversation of weight and its impact on health and offer a community of support for the individual affected.

Green Park Collaborative                
Julie Simmons                    
410-547-2687 ext. 116        

The Liver Forum
Katherine Greene, MPH 

Obesity Action Coalition
Joe Nadglowski