{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Sherry AD"],"funding":["National Institutes of Health","NIH HHS","Andrew Sabin Family Foundation"],"pagination":["256"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12289950"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["9(1)"],"pubmed_abstract":["In phase III oncology trials, superiority is defined by statistical significance using P thresholds. However, this approach has been criticized because P is continuous. Here, we reconstruct patient-level data for 230 phase III oncology trials to model the robustness of statistical significance by estimating the survival-inferred fragility index (SIFI), defined as the smallest number of patients changing arms that alters the statistical significance interpretation. The median SIFI was 8 patients (IQR 4-19), representing 1.4% of enrollments (IQR 0.7%-3%). As a continuous statistic, P-but not the significance interpretation-was correlated with SIFI. Moreover, overall survival endpoints were more fragile than surrogate endpoints. Taken together, while phase III oncology trials are intended to "],"journal":["NPJ precision oncology"],"pubmed_title":["Survival-inferred fragility of statistical significance in phase III oncology trials."],"pmcid":["PMC12289950"],"funding_grant_id":["P30CA016672"],"pubmed_authors":["Miller AM","Kouzy R","Ludmir EB","Koong A","Meirson T","El-Alam MB","McCaw ZR","Liu Y","Abi Jaoude J","Bomze D","Lin C","Ofer J","Lin TA","Msaouel P","Patel RR","Sherry AD","Owiwi M"],"additional_accession":[]},"is_claimable":false,"name":"Survival-inferred fragility of statistical significance in phase III oncology trials.","description":"In phase III oncology trials, superiority is defined by statistical significance using P thresholds. However, this approach has been criticized because P is continuous. Here, we reconstruct patient-level data for 230 phase III oncology trials to model the robustness of statistical significance by estimating the survival-inferred fragility index (SIFI), defined as the smallest number of patients changing arms that alters the statistical significance interpretation. The median SIFI was 8 patients (IQR 4-19), representing 1.4% of enrollments (IQR 0.7%-3%). As a continuous statistic, P-but not the significance interpretation-was correlated with SIFI. Moreover, overall survival endpoints were more fragile than surrogate endpoints. Taken together, while phase III oncology trials are intended to ","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Jul","modification":"2026-03-17T13:41:10.189Z","creation":"2025-08-16T03:05:31.188Z"},"accession":"S-EPMC12289950","cross_references":{"pubmed":["40707724"],"doi":["10.1038/s41698-025-01024-2"]}}