The clinically relevant endpoint

A crucial decision for successful clinical efficacy studies testing VMPs

Klifovet's 13th Workshop on GCP and Veterinary Clinical Studies took place on April 21-22, 2016, in Munich/ Germany.

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. 
This topic was the backbone of Klifovet’s 13^th Munich Workshop on VICH GCP and Veterinary Clinical Studies, taking place on April 21^st and 22^nd, 2016 in Munich. The 13^th workshop on this topic attracted 25 external participants from ten European countries. Klifovet AG is a Munich/ Germany-based veterinary CRO and regulatory consultancy offering full product development services. They received the Animal Pharm Award as “Best CRO” for 2015. 
“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”, Klaus Hellmann, CEO of Klifovet, pointed out. Typical statistical parameters applied in clinical efficacy studies were explained by Nicole Kraemer, senior statistician at Staburo, Germany: 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 result.
“Beyond a statistical confirmation of an effect, the prove of efficacy must be based on relevant criteria, for VMPs the clinical relevance is paramount”, was pointed out be Dr. Gabriel Beechinor, Head of the HPRA, 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.
For more information on specific topics, please contact the experts at KLIFOVET: info@klifovet.com.