Washington DC, Thursday, May 31, 2018– The Forum for Collaborative Research is excited to announce a new partnership with the Center for Medical Technology Policy’s (CMTP) Green Park Collaborative (GPC) 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 multi-stakeholder collaboration, including patients, clinicians, payers, HTAs, regulators, and industry organizations, that will help set how outcomes in NASH clinical trials should be measured.
NASH is a serious chronic liver disease estimated to affect more than 15 million adults in the U.S., and which can progress to cirrhosis, liver failure, cancer, and death. There are currently no approved treatments for NASH; but many compounds are 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 capture in these outcomes? What outcomes are most relevant to regulators, payers, HTA groups and guideline developers?
To address these issues, the coreNASH project will develop a Core Outcome Set, defined as “an agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical research in specific areas of health or health care[2].” The project will convene a multi-stakeholder group to develop consensus on a clearly defined core outcome set to measure the comparative effectiveness and value of treatments for NASH. The intent is for these 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.
Dr. Veronica Miller, Executive Director of the Forum for Collaborative Research and The Liver Forum, commented on the significance of this project, noting, “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.”
Dr. Sean Tunis, President and CEO of CMTP noted CMTP’s prior successful core outcome initiatives, stating, “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. 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.”
Joe Nadglowski, President and CEO of OAC touched on the need for a multi-disciplinary approach, noting, “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.”
Donna Cryer, President and CEO of the Global Liver Institute and Liver Forum Steering Committee Member further noted the importance of this project from a patient-centered perspective, stating, “This initiative builds on the powerful collaborations in the NASH space that have modeled inclusion of the patient as a full partner from the earliest stages. Moving forward together in this fashion is why although NASH is a complex disease state; the field has made steady progress by many innovators towards therapies that will add value to patients’ lives and the public health.”
The project will officially kick off on Thursday, May 31 and is anticipated to be completed in early 2019.
Project website: http://www.cmtpnet.org/green-park-collaborative/initiatives/corenash/
Project contact: Jennifer Al Naber,
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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.
The Liver Forum aims to advance the regulatory science for the treatment of non-alcoholic steatohepatitis and liver fibrosis by providing an independent and neutral platform for ongoing multi-stakeholder dialogue to identify and address gaps in the field. Neutrality and objectivity is ensured through representation and active engagement of scientific experts from all stakeholder groups, including academia, industry, patient community and regulatory agencies.
Contact Information
Katherine Greene, MPH
Senior Research Associate
Forum for Collaborative Research
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Twitter: @LiverForum