Statistical considerations in the design of albumin clinical trials

VernacularTitle:白蛋白临床试验设计中的统计学考量
Author: Yuanyuan KONG ¹ ; Chen YAO ² ; Jidong JIA ³
Author Information

1. Department of Clinical Epidemiology and Evidence-Based Medicine， Beijing Friendship Hospital， Capital Medical University， National Clinical Research Center for Digestive Diseases， Beijing 100050， China
2. Department of Medical Statistics， Peking University First Hospital， Beijing 100034， China
3. Liver Research Center， Beijing Friendship Hospital， Capital Medical University， Beijing 100050， China
Publication Type:Journal Article
Keywords: Albumins; Clinical Trials; Statistics as Topic
From: Journal of Clinical Hepatology 2025;41(3):420-423
CountryChina
Language:Chinese
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.