临床肝胆病杂志2025，Vol.41Issue(3)：420-423,4.DOI:10.12449/JCH250305
白蛋白临床试验设计中的统计学考量
Statistical considerations in the design of albumin clinical trials
摘要
Abstract
Albumin is widely used in clinical practice,and the rationality of trial design directly affects the reliability of research findings and clinical application value.This article reviews the key statistical considerations in the design of albumin clinical trials,including the selection of primary endpoints,the establishment of statistical hypotheses and non-inferiority margins,clinical evaluation criteria for ascites improvement,sample size,and interim analyses,in order to provide methodological guidance for clinical researchers to optimize clinical trial design and enhance its scientific rigor and feasibility.关键词
白蛋白类/临床试验/统计学(主题)Key words
Albumins/Clinical Trials/Statistics as Topic引用本文复制引用
孔媛媛,姚晨,贾继东..白蛋白临床试验设计中的统计学考量[J].临床肝胆病杂志,2025,41(3):420-423,4.基金项目
国家重点研发计划(2023YFC2306902,2023YFC2306900) （2023YFC2306902,2023YFC2306900）
北京市卫生健康委高层次公共卫生技术人才建设项目(学科骨干-010-018) National Key Research and Development Program(2023YFC2306902,2023YFC2306900) （学科骨干-010-018）
Beijing Municipal Health Commission High level Public Health Technical Talent Construction Project(Subject-backbones-010-018) （Subject-backbones-010-018）
