ArticlemedRxiv : the preprint server for health sciences2025
Survival-Inferred Fragility of Statistical Significance in Phase III Oncology Trials.
Article in medRxiv : the preprint server for health sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Abstract
Background: Statistical significance currently defines superiority in phase III oncology trials. However, this practice is increasingly questioned. Here, we estimated the fragility of phase III oncology trials. Methods: Using Kaplan-Meier curves for the primary endpoints of 230 two-arm superiority phase III oncology trials, we reconstructed data for individual patients. We estimated the survival-inferred fragility index (SIFI) by iteratively flipping the best responder from the experimental arm to the control arm (SIFI Results: This study included 230 trials enrolling 184,752 patients. The median number of patients required to change trial interpretation was 8 (interquartile range, 4 to 19) or 1.4% (interquartile range, 0.7% to 3%) per SIFI Conclusions: Even among phase III oncology trials, which directly inform patient care, changes in the outcomes of few patients are often sufficient to change statistical significance and trial interpretation. These findings imply that current definitions of statistical significance used in phase III oncology are inadequate to identify replicable findings.
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