Regulatory Focus™ > News Articles > New Guideline on Statistical Principles for Veterinary Clinical Trials Released by EMA

New Guideline on Statistical Principles for Veterinary Clinical Trials Released by EMA

Posted 23 January 2012 | By Alexander Gaffney, RAC 

A new guideline released by the European Medicines Agency (EMA) on 23 January updates the agency's thinking on the statistical principles to be considered while investigating veterinary pharmaceutical products.

The guidance, Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals), is similar to its human medicines counterpart (Guidance on Statistical Principles or Clinical Trials), and provides insight on the design, conduct, analysis and evaluation of clinical trials used to demonstrate safety and/or efficacy of veterinary medicinal products.

The guideline focuses on statistical principles, and "assumes the use of validated and clinically meaningful parameters as well as relevant inclusion and exclusion criteria." It does not delve in to great detail regarding the specific statistical procedures or methods, but notes that responsibility for all statistical work needs to be conducted by an appropriately qualified statistician.

Further, "the extent to which the procedures in the protocol are followed and the primary analysis is planned a priori will contribute to the degree of confidence in the final results and conclusions of the trial."

The guideline notes a long list of considerations necessary for conducting a clinical trial, including:

  • The type of clinical trial (e.g. exploratory or confirmatory)
  • The scope of the study to be conducted, including the population and study variables
  • Design techniques to avoid bias such as randomization and blinding
  • Study design, including control groups to be used, the type of trial design and controls across multiple clinical centers
  • Types of comparison (e.g. superiority of non-inferiority) and dose response designs

Other considerations include group sequential designs, experimental units, sample size, meta-analysis, study conduct, recruitment rates, interim analysis, data analysis, evaluation of target animal safety and reporting.

The guideline comes in to effect on 1 August 2012.

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