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[Study design in clinical radiologic research].

PURPOSE
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.


CONCLUSION
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.