机构：[1]Department of Infectious Diseases, The Key Discipline of Gguangdong Province, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, #151 Yanjiang Road, Guangzhou 510120, Guangdong Province, China[2]Department of liver diseases (I), The Hospital Affiliated to Shaanxi University of Chinese Medicine, Xianyang 712000, Shaanxi Province, China
The fragility index (FI) of trial results can provide a measure of confidence in the positive effects reported in randomized controlled trials (RCTs). The aim of this study was to calculate the FI of RCTs supporting HCC treatments.
A methodological systematic review of RCTs in HCC treatments was conducted. Two-arm studies with randomized and positive results for a time-to-event outcome were eligible for the FI calculation.
A total of 6 trails were included in this analysis. The median FI was 0.5 (IQR 0-10). FI was ≤7 in 4 (66.7%) of 6 trials; in those trials the fragility quotient was ≤1%.
Many phase 3 RCTs supporting HCC treatments have a low FI, which challenges the confidence in concluding the superiority of these drugs over control treatments.
基金：
This study was partly supported by the grant from the National Natural
Science Foundation of China (No. 81603612); the Science and Technology
Department of Shaanxi Province (NO.2018KJXX-093), and Innovation Team of
Shaanxi University of Traditional Chinese Medicine (NO.2019-YL05).
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2020]版：
大类|3 区医学
小类|3 区肿瘤学
最新[2025]版：
大类|3 区医学
小类|3 区肿瘤学
第一作者：
第一作者机构：[1]Department of Infectious Diseases, The Key Discipline of Gguangdong Province, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, #151 Yanjiang Road, Guangzhou 510120, Guangdong Province, China
通讯作者：
推荐引用方式(GB/T 7714)：
Zhang Hao,Li Jingtao,Zeng Wenting.Frequent fragility of randomized controlled trials for HCC treatment.[J].BMC cancer.2021,21(1):389.doi:10.1186/s12885-021-08133-8.
APA：
Zhang Hao,Li Jingtao&Zeng Wenting.(2021).Frequent fragility of randomized controlled trials for HCC treatment..BMC cancer,21,(1)
MLA：
Zhang Hao,et al."Frequent fragility of randomized controlled trials for HCC treatment.".BMC cancer 21..1(2021):389
