Collaboration launches initiative to develop NASH outcome consensus

The Center for Medical Technology Policy’s Green Park Collaborative, the Forum for Collaborative Research and the Obesity Action Coalition announced the launch of its ‘coreNASH’ initiative, designed to develop a consensus on critical outcomes in nonalcoholic steatohepatitis clinical research, according to a press release.

The initiative will involve a multi-stakeholder team, including clinicians, patients with NASH, payers, health technology assessment groups, regulators and life sciences companies, who will help establish a consistent and stakeholder-relevant baseline for evaluation of NASH therapies.

“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,” Sean Tunis, president and CEO of the Center for Medical Technology Policy, said in the release. “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.”

According to the press release, the coreNASH team expects to publish a white paper and accompanying peer-reviewed article with its consensus mid-year in 2019.

References: www.cmtpnet.org/green-park-collaborative; www.forumresearch.org; www.obesityaction.org