Frequent fragility of randomized controlled trials for HCC treatment

BMC Cancer

Hao Zhang¹  Wenting Zeng¹  Jingtao Li² 

[1] Department of Infectious Diseases, The Key Discipline of Gguangdong Province, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, #151 Yanjiang Road, 510120, Guangzhou, Guangdong Province, China;Department of liver diseases (I), The Hospital Affiliated to Shaanxi University of Chinese Medicine, 712000, Xianyang, Shaanxi Province, China;

关键词: Fragility index;    Randomized controlled trials;    Endpoint;   

DOI  :  10.1186/s12885-021-08133-8

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsA 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.ResultsA 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%.ConclusionMany phase 3 RCTs supporting HCC treatments have a low FI, which challenges the confidence in concluding the superiority of these drugs over control treatments.

【 授权许可】

CC BY