Guidance on statistical principles for clinical trials for immunological veterinary medicinal products - Scientific guideline

This document reflects the need for a guideline on appropriate statistical evaluation and interpretation of data from clinical trials for immunological veterinary medicinal products.

Keyword: Clinical trials, statistical principles, immunological veterinary medicinal product (IVMP)

Current effective version

Draft concept paper on guidance on statistical principles for clinical trials for immunological veterinary medicinal products

Draft: consultation closed Consultation dates: 18/12/2015 to 31/03/2016 Reference Number: EMA/CVMP/IWP/309514/2015 Summary:

A guideline on statistical principles for veterinary clinical trials for veterinary medicinal products (pharmaceuticals) (EMA/CVMP/EWP/81976/2010) was adopted in 2012. This guideline provides 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.