Dr Klaus Hellman, the chief executive of Klifovet, gives Animal Pharm an insight into the science and statistics behind clinical endpoints. This exclusive insight explains why is this data so crucial to the animal health sector.

Clinical studies are a pre-requisite to assess the efficacy of veterinary medicinal products (VMPs). Most important is the choice of one or more clinically relevant endpoints that show the effect of the tested product.

The indication of a VMP granted by regulatory authorities is primarily dependent on the selection of one or more endpoints that have clinical relevance and can be proven statistically in dose titration, dose confirmation and field studies.

This topic was the backbone of Klifovet's 13th Munich Workshop on VICH Good Clinical Practice and Veterinary Clinical Studies, which took place on April 21 and 22, 2016 in Munich. The workshop on this topic attracted 25 external participants from 10 European countries.

At the workshop, typical statistical parameters applied in clinical efficacy studies were explained by Nicole Kraemer, senior statistician at Staburo, a statistical services company based in Germany.

These parameters were: a statistical power of ≥80%, ß of 0.20 and a one-sided significance level of p≤0.05. In case of non-inferiority studies (positive controlled), the non-inferiority margin must be well justified, applying these criteria (where appropriate).

These statistically agreed criteria have to be applied when planning replicate numbers to assure obtaining meaningful study results.

"Beyond a statistical confirmation of an effect, the proof of efficacy must be based on relevant criteria, for VMPs the clinical relevance is paramount," said Dr Gabriel Beechinor, head of the Health Products Regulatory Authority, Ireland.

He called the primary endpoint a key element for studies to prove the efficacy of a drug. Consequently, it is a decisive factor for a positive benefit-risk evaluation by the authorities and hence the success of a dossier.

Klifovet is a Munich, Germany-based veterinary clinical research organization and regulatory consultancy offering full product development services. Earlier this year, the company highlighted a lack of regulations for novel veterinary therapeutics.

Read the original Article on AnimalPharm online here!