Counterfactual mediation analysis in the multistate model framework for surrogate and clinical time‐to‐event outcomes in randomized controlled trials

2021 ◽  
Author(s):  
Isabelle R. Weir ◽  
Jennifer R. Rider ◽  
Ludovic Trinquart
Keyword(s):  
Randomized Controlled Trials ◽  
Mediation Analysis ◽  
Controlled Trials ◽  
Time To Event ◽  
Multistate Model ◽  
Model Framework ◽  
Randomized Controlled

scholarly journals An audit strategy for time-to-event outcomes measured with error: Application to five randomized controlled trials in oncology

2013 ◽  
Vol 10 (5) ◽  
pp. 754-760 ◽  
Author(s):  
Lori E Dodd ◽  
Edward L Korn ◽  
Boris Freidlin ◽  
Wenjuan Gu ◽  
Jeffrey S Abrams ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Time To Event ◽  
Randomized Controlled ◽  
Audit Strategy

scholarly journals Frequent fragility of randomized controlled trials for HCC treatment

2020 ◽  
Author(s):  
Zhang Hao ◽  
Li Jingtao ◽  
Wenting Zeng
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Fragility Index ◽  
Time To Event ◽  
Phase 3 ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Positive Results

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.

scholarly journals Frequent fragility of randomized controlled trials for HCC treatment

2020 ◽  
Author(s):  
Zhang Hao ◽  
Li Jingtao ◽  
Wenting Zeng
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Fragility Index ◽  
Time To Event ◽  
Phase 3 ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Calculation Results ◽  
Positive Results

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.

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