title: [Study design in clinical radiologic research].
abstract: OBJECTIVE
  To review important aspects of study design in clinical radiology and to introduce the reader to the requirements of Good Clinical Practice (GCP).
  
  
  METHODS
  The European guidelines for GCP, the Declaration of Helsinki, the differentiation into study phases and the authors' own experience in open and sponsored clinical trials are the basis of this analysis.
  
  
  RESULTS
  Guideline such as GCP do not limit scientific freedom in research but define high standards for the well-being of patients and volunteers as well as guaranteeing scientific honesty. The benefits of defined data monitoring and the necessity of a prospective statistical concept are frequently underestimated.
  
  
  CONCLUSIONS
  Correct study design has to be expected in radiology too. High standards guarantee accuracy and honesty of scientific studies. Only this can warrant the value for the patient of radiological diagnostics and therapy.
authors.affiliation: Forschungsschwerpunkt Radiologische Diagnostik und Therapie, Deutsches Krebsforschungszentrum (dkfz), Heidelberg.
authors.forename: M V
authors.initials: MV
authors.lastname: Knopp
authors.forename: F
authors.initials: F
authors.lastname: Floemer
authors.forename: I
authors.initials: I
authors.lastname: Zuna
authors.forename: G
authors.initials: G
authors.lastname: van Kaick
mesh_terms: D005544:Forecasting; D005858:Germany; D006801:Humans; D017410:Practice Guidelines as Topic; D011871:Radiology / Q000639:trends*; D016032:Randomized Controlled Trials as Topic / Q000639:trends*; D012107:Research Design
vernacular_title: Studiendesign in der klinisch radiologischen Forschung.