[Statistical principles of "good clinical practice" in veterinary medicine--a position paper for planning, implementation and evaluation of empirical studies].
The complexity of the design, conduct, analysis and evaluation of empirical studies necessitates a high degree of interdisciplinary collaboration in all areas of research. In order to make sure that no essential harmonisation is missed among the plenitude of processes, it has become common to provide direction on the essential operating procedures in so called "Good ... Practice" guidelines in recent years. In pharmaceutical research on human medicinal products guidelines on Good Clinical Practice have been an integral part of research and development in industry, academia, and the regulatory authorities for a long time. On the other hand, in the development and registration of pharmaceuticals for veterinary use such procedures are not yet established to this extent in Germany. Notwithstanding there being a lot of regulations on specialised subjects. This paper tries to summarise the current state of the discussion and to give an overview on the important points in the design, conduct, analysis and reporting of veterinary clinical studies mainly from an biometrical point of view.
Glaser
S
S
Institut für Biometrie, Epidemiologie und Informationsverarbeitung an der Tierärztlichen Hochschule Hannover. sabine.glaser@tiho-hannover.de
Dahms
S
S
Röhmel
J
J
Weiss
H
H
Kreienbrock
L
L
D000818:Animals; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*; D012106:Research; D014730:Veterinary Medicine