Core Outcome Measures in Effectiveness Trials

coreNASH: Developing core outcomes for Nonalcoholic Steatohepatitis (NASH)

General Information

Summary:
Nonalcoholic steatohepatitis (NASH) is a serious chronic liver disease that is estimated to affect over 15 million adults in the United States, and it is projected to surpass chronic hepatitis C infection as the primary indication for liver transplantation by 2020. There are currently no Food and Drug Administration (FDA) approved pharmacologic therapies for NASH, and current approaches to treatment—including weight loss drugs, Vitamin E, statins, metformin, and pioglitazone—are associated with significant risks and side effects while offering only marginal benefits. The increasing burden of NASH and corresponding lack of effective therapies has spurred the development of several new pharmacologic treatments. The objective of the project is to develop a “core set” of outcomes – a minimum set of outcomes recommended to be included in all clinical studies of NASH treatments.

Contributors:
Center for Medical Technology Policy, Green Park Collaborative (principle supervisors) [Elizabeth Clearfield: elizabeth.clearfield@cmtpnet.org],
The Forum for Collaborative Research – Liver Forum,
Obesity Action Coalition

Further Study Information

Current Stage:
Ongoing
Date:
May 2018 - January 2019
Funding source(s):
* Allergan, * Intercept Pharmaceuticals, * Nusirt Biopharma, * Pfizer, * Other multinational pharmaceutical companies (TBA)

Health Area

Disease Category
Gastroenterology

Disease Name
Nonalcoholic Fatty Liver Disease (NAFLD)
Nonalcoholic steatohepatitis (NASH)

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Drug

Method(s)

Consensus meeting
Delphi process
Interview
Literature review

The core outcome set will be developed through a consensus process utilizing online Delphi voting and culminating in an in-person consensus meeting. Literature review and key informant interviews will be used to create a candidate list of outcomes; a Steering Committee will review and provide recommendations for additional outcomes to consider, and develop standard clinically-accurate definitions to be used throughout. The Delphi process will be used to condense and prioritize the outcome list. The in-person consensus meeting will include a final round of Delphi voting to confirm the recommended core outcome set.


Stakeholders Involved

Clinical experts
Consumers (patients)
Economists
Epidemiologists
Governmental agencies
Methodologists
Patient/ support group representatives
Pharmaceutical industry representatives
Regulatory agency representatives
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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