EMEA: Concept paper on the Revision of the guideline on statistical priniples for veterinary clinical trials

The guideline on statistical principles for veterinary clinical trials was adopted in June 2002. Since then it has been referred to extensively in full application dossiers including clinical trials in the target species, mainly clinical field studies. The guideline is basically similar to its counterpart in human medicine (Note for Guidance on Statistical Principles for Clinical Trials, CPMP/ICH/363/96) and addresses, in addition, specific veterinary issues.