Frequent fragility of randomized controlled trials for HCC treatment
Hao Zhang,
Jingtao Li,
Wenting Zeng
Affiliations
Hao Zhang
Department of Infectious Diseases, The Key Discipline of Gguangdong Province, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University
Jingtao Li
Department of liver diseases (I), The Hospital Affiliated to Shaanxi University of Chinese Medicine
Wenting Zeng
Department of Infectious Diseases, The Key Discipline of Gguangdong Province, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University
Abstract 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.
