AI Article Synopsis
- The 'Table 1 Fallacy' is when researchers misuse significance testing to incorrectly assess balance in baseline variables between randomized groups in clinical trials, leading to potential misinterpretations.
- In a study of 765 phase III oncology trials with over half a million patients, the fallacy was found in 25% of trials, with only 3% of comparisons deemed statistically significant, which is close to the expected type I error rate of 5%.
- Factors that reduced the likelihood of encountering the fallacy included industry sponsorship, larger trial sizes, and publication in European journals, indicating a need for improved practices in reporting and analyzing trial data to avoid misleading conclusions.
Article Abstract
Background: The 'Table 1 Fallacy' refers to the unsound use of significance testing for comparing the distributions of baseline variables between randomised groups to draw erroneous conclusions about balance or imbalance. We performed a cross-sectional study of the Table 1 Fallacy in phase III oncology trials.
Methods: From ClinicalTrials.gov, 1877 randomised trials were screened. Multivariable logistic regressions evaluated predictors of the Table 1 Fallacy.
Results: A total of 765 randomised controlled trials involving 553,405 patients were analysed. The Table 1 Fallacy was observed in 25% of trials (188 of 765), with 3% of comparisons deemed significant (59 of 2353), approximating the typical 5% type I error assertion probability. Application of trial-level multiplicity corrections reduced the rate of significant findings to 0.3% (six of 2345 tests). Factors associated with lower odds of the Table 1 Fallacy included industry sponsorship (adjusted odds ratio [aOR] 0.29, 95% confidence interval [CI] 0.18-0.47; multiplicity-corrected P < 0.0001), larger trial size (≥795 versus <280 patients; aOR 0.32, 95% CI 0.19-0.53; multiplicity-corrected P = 0.0008), and publication in a European versus American journal (aOR 0.06, 95% CI 0.03-0.13; multiplicity-corrected P < 0.0001).
Conclusions: This study highlights the persistence of the Table 1 Fallacy in contemporary oncology randomised controlled trials, with one of every four trials testing for baseline differences after randomisation. Significance testing is a suboptimal method for identifying unsound randomisation procedures and may encourage misleading inferences. Journal-level enforcement is a possible strategy to help mitigate this fallacy.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11512581 | PMC |
| http://dx.doi.org/10.1016/j.ejca.2023.113357 | DOI Listing |
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Article Synopsis
- The 'Table 1 Fallacy' is when researchers misuse significance testing to incorrectly assess balance in baseline variables between randomized groups in clinical trials, leading to potential misinterpretations.
- In a study of 765 phase III oncology trials with over half a million patients, the fallacy was found in 25% of trials, with only 3% of comparisons deemed statistically significant, which is close to the expected type I error rate of 5%.
- Factors that reduced the likelihood of encountering the fallacy included industry sponsorship, larger trial sizes, and publication in European journals, indicating a need for improved practices in reporting and analyzing trial data to avoid misleading conclusions.
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