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@ARTICLE{Kppe:310094,
      author       = {J. Köppe and A. Schiel and C. Gerlinger and H. Götte and
                      D. Edelmann$^*$ and S. Erdmann},
      title        = {{I}ntegration of {R}eal-{W}orld {D}ata into {C}linical
                      {T}rials: {A}n {I}nterdisciplinary {D}iscussion from
                      {R}egulatory and {P}ractical {P}erspectives. [{E}inbindung
                      von versorgungsnahen {D}aten in klinische {S}tudien –
                      {I}nterdisziplinäre {D}iskussion aus regulatorischer und
                      anwendungsbezogener {S}icht].},
      journal      = {Das Gesundheitswesen},
      volume       = {nn},
      issn         = {0941-3790},
      address      = {Stuttgart [u.a.]},
      publisher    = {Thieme},
      reportid     = {DKFZ-2026-00438},
      pages        = {nn},
      year         = {2026},
      note         = {epub},
      abstract     = {Increasing efforts are required to integrate the growing
                      volume of so-called real-world data (also named routine
                      practice data), which are data generated outside of
                      randomized controlled trials, into regulatory studies.
                      Various stakeholders anticipate that such integration could
                      save time and financial resources during the approval
                      process of new therapies, and ethical considerations also
                      partially support such an approach. The aim of this
                      manuscript is to provide an overview of the methodological,
                      ethical, and regulatory considerations when integrating
                      routine practice data into randomized controlled trials. It
                      targets clinical researchers, biostatisticians, regulators,
                      and decision-makers involved in evidence generation and
                      trial design.The inclusion of real-world data in randomized
                      controlled trials can be meaningful from both ethical and
                      economic perspectives. However, implementing this requires
                      addressing various and sometimes significant limitations of
                      the data, which need to be methodologically addressed.
                      Therefore, it is essential to carefully weigh the risks and
                      benefits of incorporating real world data into clinical
                      studies.Randomized trials remain the gold standard for
                      evaluating the efficacy of new therapies. Nevertheless,
                      real-world data have the potential to improve the complex
                      and costly process of drug development. The assessment of
                      the potential for a specific clinical study should be made
                      in collaboration with all relevant stakeholders. Apart from
                      that, real-world data have a substantial potential to expand
                      the evidence from randomized trials after post-market
                      approval, thereby ensuring the safety of all patients.},
      subtyp        = {Review Article},
      cin          = {C060},
      ddc          = {610},
      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:41730277},
      doi          = {10.1055/a-2736-6561},
      url          = {https://inrepo02.dkfz.de/record/310094},
}