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@ARTICLE{Kunz:127827,
      author       = {C. Kunz$^*$ and M. Kieser},
      title        = {{B}linded versus unblinded covariate selection in
                      confirmatory survival trials.},
      journal      = {Journal of biopharmaceutical statistics},
      volume       = {24},
      number       = {2},
      issn         = {1520-5711},
      address      = {Philadelphia, PA},
      publisher    = {Taylor $\&$ Francis},
      reportid     = {DKFZ-2017-03849},
      pages        = {398 - 414},
      year         = {2014},
      abstract     = {Adjustment for covariates and specification of the correct
                      covariate set are important issues in the analysis of
                      clinical trials. Edwards (1999) proposes a model selection
                      approach where the model is chosen on the final data set,
                      which remains blinded for treatment group allocation. We
                      investigate this method for time-to-event endpoints and
                      compare its performance to variable selection within an
                      adaptive design. This adaptive design integrates the methods
                      of Schäfer and Müller (2001) and Keiding et al. (1987) and
                      allows variable selection on the unblinded data during an
                      interim analysis. Monte Carlo simulation shows that Edwards'
                      method-though blinded-outperforms the adaptive method in
                      terms of ability to select the survival relevant covariates
                      and power. The application of the methods is illustrated by
                      a clinical trial example.},
      cin          = {C060},
      ddc          = {570},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {313 - Cancer risk factors and prevention (POF3-313)},
      pid          = {G:(DE-HGF)POF3-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:24605976},
      doi          = {10.1080/10543406.2013.860158},
      url          = {https://inrepo02.dkfz.de/record/127827},
}