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Published on: September 30, 2021
Frequent fragility of randomized controlled trials for HCC treatment
Hao Zhang1, Jingtao Li2, Wenting Zeng3
1Department 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.
Background:
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.
Methods:
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.
Results:
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%.
Conclusion:
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.
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