ArticleGastroenterology report2026
Assessing the robustness of clinical trials regarding novel therapies in inflammatory bowel disease.
Article in Gastroenterology report, 2026. 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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Authors and funding
6 authors.
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Abstract
Background: Increasing randomized clinical trials evaluating novel therapies for inflammatory bowel disease necessitated the scrutiny of statistical robustness. This study aimed to quantify their fragility and identify factors associated with robustness. Methods: This cross-sectional analysis included randomized clinical trials studying biologics, small-molecule inhibitors, fecal microbiota transplantation (FMT), and stem cell therapy (SCT), and then the calculated fragility index (FI) and continuous fragility index (CFI) for binary and continuous outcomes, respectively. Factors affecting robustness were analysed through correlation analysis and multiple linear regression. Results: Among 129 trials from 53 studies, the median FI and CFI were 6 and 14.8, respectively. The FI varied significantly by the treatment type, trial phase, outcome type, and Conclusion: Randomized clinical trials of novel inflammatory bowel disease therapies exhibit varying robustness and are influenced by multiple study characteristics. Trials of biologics or small molecules, those with positive primary outcomes, and larger studies demonstrated greater robustness, supporting that robustness should be considered in future research when interpreting the efficacy.
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