Statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) - Scientific guideline

This document provide guidance on the statistical principles to be considered in the design, conduct, analysis and evaluation of clinical trials to demonstrate efficacy and/or safety of an investigational veterinary pharmaceutical product in animals.

Keywords: Veterinary medicinal products, statistical principles, pre-clinical studies, clinical trials, study design, study conduct, data analysis, reporting.

Current version - effective from 28/01/2022

Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) - Rev. 1

Adopted Reference Number: EMA/CVMP/EWP/81976/2010 Rev.1 Legal effective date: 28/01/2022

Document history

Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals)

Adopted Consultation dates: 10/01/2012 to 31/07/2012 Reference Number: EMA/CVMP/EWP/81976/2010 Legal effective date: 01/08/2012 Summary:

This revised note is intended to provide guidance on the statistical principles to be considered in the design, conduct, analysis and evaluation of clinical trials to demonstrate efficacy and/or safety of an investigational veterinary pharmaceutical product in animals.

Overview of comments received on 'Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals)'

Reference Number: EMA/CVMP/EWP/249785/2011

Draft guideline on statistical principles for veterinary clinical trials

Draft: consultation closed Consultation dates: 15/09/2010 to 31/03/2011 Reference Number: EMA/CVMP/EWP/81976/2010

Concept paper on the revision of the guideline on statistical principles for veterinary clinical trials (EMEA/CVMP/816/00)

Reference Number: EMEA/CVMP/EWP/37388/2009