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@ARTICLE{Sherry:284657,
      author       = {A. D. Sherry and P. Msaouel and Z. R. McCaw and J. Abi
                      Jaoude and E. J. Hsu and R. Kouzy and R. Patel and Y. Yang
                      and T. A. Lin and C. M. Taniguchi and C. Rödel$^*$ and E.
                      Fokas$^*$ and C. Tang and C. D. Fuller and B. Minsky and T.
                      Meirson and R. Sun and E. B. Ludmir},
      title        = {{P}revalence and implications of significance testing for
                      baseline covariate imbalance in randomised cancer clinical
                      trials: {T}he {T}able 1 {F}allacy.},
      journal      = {European journal of cancer},
      volume       = {194},
      issn         = {0014-2964},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2023-02058},
      pages        = {113357},
      year         = {2023},
      abstract     = {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.From ClinicalTrials.gov, 1877
                      randomised trials were screened. Multivariable logistic
                      regressions evaluated predictors of the Table 1 Fallacy.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).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.},
      keywords     = {Covariate imbalance (Other) / Oncology (Other) / Phase III
                      (Other) / Randomised controlled trials (Other) /
                      Significance testing for baseline characteristics (Other) /
                      Table 1 Fallacy (Other) / Testing for baseline differences
                      (Other)},
      cin          = {FM01},
      ddc          = {610},
      cid          = {I:(DE-He78)FM01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37827064},
      doi          = {10.1016/j.ejca.2023.113357},
      url          = {https://inrepo02.dkfz.de/record/284657},
}