Frequent fragility of randomized controlled trials for HCC treatment

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.