An excerpt of EASL-AASLD Delphi consensus statement on surrogate endpoints and real-world evidence in primary biliary cholangitis （2026）
- VernacularTitle:《2026年欧洲肝病学会和美国肝病学会德尔菲共识声明： 原发性胆汁性胆管炎替代终点和真实世界证据》摘译
- Author:
Qichao GE
1
;
Xiaobo CAI
1
;
Lungen LU
1
Author Information
- Publication Type:Journal Article
- Keywords: Primary Biliary Cholangitis; Surrogate Endpoint; Real-World Evidence; Europe; United States; Consensus
- From: Journal of Clinical Hepatology 2026;42(8):1807-1814
- CountryChina
- Language:Chinese
- Abstract: In 2026， the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases jointly published a Delphi consensus statement on surrogate endpoints and real-world evidence in primary biliary cholangitis. This consensus proposes 16 statements and 42 recommendations centering on the following three most critical issues in the development of new drugs for primary biliary cholangitis： whether liver biochemical parameters and noninvasive assessments of liver fibrosis can be used as surrogate endpoints for clinical outcomes； how real-world data and real-world evidence can complement or support confirmatory studies in a manner compliant with regulatory requirements； how patient-reported outcomes can be standardized for the assessment of quality of life， pruritus， and fatigue. This article provides an excerpt and expert interpretation of the background， methodological framework， core statements， recommendations， and key figures and tables of this consensus， in order to provide a reference for the diagnosis and treatment of primary biliary cholangitis， drug evaluation， real-world study design， and the development of patient-centered clinical endpoints in China.
