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 11 trails were included in this analysis. The median FI was 0 (range 0-19). FI was ≤ 5 in 8 (72.73%) of 11 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.