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@ARTICLE{Calderazzo:286009,
      author       = {S. Calderazzo$^*$ and M. Wiesenfarth$^*$ and A.
                      Kopp-Schneider$^*$},
      title        = {{R}obust incorporation of historical information with known
                      type {I} error rate inflation.},
      journal      = {Biometrical journal},
      volume       = {66},
      number       = {1},
      issn         = {0323-3847},
      address      = {Berlin},
      publisher    = {Wiley-VCH},
      reportid     = {DKFZ-2023-02586},
      pages        = {e2200322},
      year         = {2024},
      note         = {#EA:C060#LA:C060# / 2024 Jan;66(1):e2200322},
      abstract     = {Bayesian clinical trials can benefit from available
                      historical information through the specification of
                      informative prior distributions. Concerns are however often
                      raised about the potential for prior-data conflict and the
                      impact of Bayes test decisions on frequentist operating
                      characteristics, with particular attention being assigned to
                      inflation of type I error (TIE) rates. This motivates the
                      development of principled borrowing mechanisms, that strike
                      a balance between frequentist and Bayesian decisions.
                      Ideally, the trust assigned to historical information
                      defines the degree of robustness to prior-data conflict one
                      is willing to sacrifice. However, such relationship is often
                      not directly available when explicitly considering inflation
                      of TIE rates. We build on available literature relating
                      frequentist and Bayesian test decisions, and investigate a
                      rationale for inflation of TIE rate which explicitly and
                      linearly relates the amount of borrowing and the amount of
                      TIE rate inflation in one-arm studies. A novel dynamic
                      borrowing mechanism tailored to hypothesis testing is
                      additionally proposed. We show that, while dynamic borrowing
                      prevents the possibility to obtain a simple closed-form TIE
                      rate computation, an explicit upper bound can still be
                      enforced. Connections with the robust mixture prior
                      approach, particularly in relation to the choice of the
                      mixture weight and robust component, are made. Simulations
                      are performed to show the properties of the approach for
                      normal and binomial outcomes, and an exemplary application
                      is demonstrated in a case study.},
      keywords     = {Bayesian trial design (Other) / borrowing of historical
                      information (Other) / robust borrowing (Other) / type I
                      error rate (Other)},
      cin          = {C060},
      ddc          = {570},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
      pid          = {G:(DE-HGF)POF4-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:38063813},
      doi          = {10.1002/bimj.202200322},
      url          = {https://inrepo02.dkfz.de/record/286009},
}