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Summary and reflections on the interim analysis of confirmatory clinical trials
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Ming-li HENG1, Si-rui ZHONG2, Chen-bo ZHANG1, Feng-yu SUN1
Chinese Journal of Clinical Pharmacology | 2025, 41(19) : 2841 - 2843
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Chinese Journal of Clinical Pharmacology | 2025, 41(19): 2841-2843
Drug Evaluation and Administration
Summary and reflections on the interim analysis of confirmatory clinical trials
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Ming-li HENG1, Si-rui ZHONG2, Chen-bo ZHANG1, Feng-yu SUN1
Affiliations
  • 1.Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
  • 2.Guangdong-Hong Kong-Macao Greater Bay Area Center for Drug Evaluation and Inspection, National Medical Products Administration, Shenzhen 518000, Guangdong Province, China
Published: 2025-10-17 doi: 10.13699/j.cnki.1001-6821.2025.19.022
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Objective

With the release of guidance for adaptive design in clinical trials both domestically and internationally, designing interim analyses in clinical trials has great guiding significance for the success of clinical trials. It not only helps to improve research and development efficiency, but also has important preventive significance for clinical trials that have chosen incorrect statistical methods, resulting in serious issues such as type I error inflation and introduction of bias, which may lead to the failure of clinical trials. This article combines three cases that have occurred in current clinical trials to analyze and summarize the statistical issues related to confirmatory clinical trial interim analyses, promoting a deeper understanding of interim analyses and providing references for the high-quality design, implementation, analysis, and interpretation of results of confirmatory clinical trials..

clinical trial  /  interim analysis  /  statistics
Ming-li HENG, Si-rui ZHONG, Chen-bo ZHANG, Feng-yu SUN. Summary and reflections on the interim analysis of confirmatory clinical trials[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (19) : 2841 -2843 . DOI: 10.13699/j.cnki.1001-6821.2025.19.022
Year 2025 volume 41 Issue 19
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Article Info
doi: 10.13699/j.cnki.1001-6821.2025.19.022
  • Receive Date:2025-08-23
  • Online Date:2026-08-05
  • Published:2025-10-17
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  • Received:2025-08-23
Affiliations
    1.Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
    2.Guangdong-Hong Kong-Macao Greater Bay Area Center for Drug Evaluation and Inspection, National Medical Products Administration, Shenzhen 518000, Guangdong Province, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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