Frequent fragility of randomized controlled trials for HCC treatment.

Authors :: Zhang H
Li J
Zeng W
Source :: BMC cancer [BMC Cancer] 2021 Apr 09; Vol. 21 (1), pp. 389. Date of Electronic Publication: 2021 Apr 09.
Publication Year :: 2021
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.<br />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.<br />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%.<br />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.