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Efficient Diagnostic Studies

Key person: Werner Vach

Collaborators: Wolfgang Weber (Department of Nuclear Medicine, Medical Center - University of Freiburg), Oke Gerke (Odense University Hospital, Denmark), Poul Flemming Hoilund-Carlsen (Odense University Hospital, Denmark)


Many medical fields are characterized today by increasing possibilities to characterize patients with respect to the state and type of disease, especially due to the advances in molecular biology and image analysis. Hence diagnostic processes and diagnostic studies play an increasingly important role. However, diagnostic studies are often designed and analysed in a fashion, which had not changed substantially over the last two decades.


We contribute to improving the design and analysis of diagnostic studies by taking a fresh look on the established principles and the new challenges arising for example from high dimensional data. Especially we work on 

  • the implementation of strategies supporting a joint evaluation of sensitivity and specificity in diagnostic studies
  • the development of guidelines for non-standard diagnostic studies, e.g. with multiple raters or multiple decisions
  • the development of approaches to demonstrate the long term clinical benefit of new diagnostic modalities, preferable without undertaking long term studies
  • the development of guidelines and methods to take practical issues like centre effects or interim analyses into account
  • the development of strategies to analyse pilot studies involving high dimensional profiles, which are too small to develop reliable diagnostics rules