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An excerpt of EASL-AASLD Delphi consensus statement on surrogate endpoints and real-world evidence in primary biliary cholangitis (2026)
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Qichao Ge, Xiaobo Cai, Lungen Lu
Journal of Clinical Hepatology | 2026, 42(8) : 1807 - 1814
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Journal of Clinical Hepatology | 2026, 42(8): 1807-1814
• Guideline •
An excerpt of EASL-AASLD Delphi consensus statement on surrogate endpoints and real-world evidence in primary biliary cholangitis (2026)
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Qichao Ge, Xiaobo Cai, Lungen Lu
Affiliations
  • Department of Gastroenterology,Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200080,China
Published: 2026-08-25 doi: 10.12449/JCH260811
Outline
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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.

Primary Biliary Cholangitis  /  Surrogate Endpoint  /  Real-World Evidence  /  Europe  /  United States  /  Consensus
葛启超, 蔡晓波, 陆伦根. 《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. 临床肝胆病杂志, 2026 , 42 (8) : 1807 -1814 . DOI: 10.12449/JCH260811
Qichao Ge, Xiaobo Cai, Lungen Lu. An excerpt of EASL-AASLD Delphi consensus statement on surrogate endpoints and real-world evidence in primary biliary cholangitis (2026)[J]. Journal of Clinical Hepatology, 2026 , 42 (8) : 1807 -1814 . DOI: 10.12449/JCH260811
Year 2026 volume 42 Issue 8
112
51
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doi: 10.12449/JCH260811
  • Receive Date:2026-06-15
  • Online Date:2026-10-16
  • Published:2026-08-25
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  • Received:2026-06-15
  • Accepted:2026-07-09
Affiliations
    Department of Gastroenterology,Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200080,China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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