Statistical considerations in the design of albumin clinical trials

Yuanyuan KONG; Chen YAO; Jidong JIA

doi:10.12449/JCH250305

Volume 41 Issue 3

Mar. 2025

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Article Navigation > Journal of Clinical Hepatology > 2025 > 41(3): 420-423

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Statistical considerations in the design of albumin clinical trials

DOI: 10.12449/JCH250305

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

Research funding:

National Key Research and Development Program (2023YFC2306902);

National Key Research and Development Program (2023YFC2306900);

Beijing Municipal Health Commission High level Public Health Technical Talent Construction Project (Subject-backbones-010-018)

More Information

Corresponding author: KONG Yuanyuan， kongyy@ccmu.edu.cn （ORCID： 0000-0002-2586-1443）
Received Date: 2024-12-23
Accepted Date: 2024-12-30
Published Date: 2025-03-25

Abstract

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.
- Albumins,
- Clinical Trials,
- Statistics as Topic

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References(18)

References

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Statistical considerations in the design of albumin clinical trials

DOI: 10.12449/JCH250305

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通讯作者: 陈斌, bchen63@163.com

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Statistical considerations in the design of albumin clinical trials

DOI: 10.12449/JCH250305

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