中文English
ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R

Statistical considerations in the design of albumin clinical trials

DOI: 10.12449/JCH250305
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
  • 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.

     

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