All Times EDT
Keywords: veterinary drug development, clinical trials, adaptive designs, biomarkers
The four guidance documents published by CVM in 2021 represent a welcome initiative to promote translation of many of the novel statistical and clinical approaches already successfully implemented in the human pharmaceutical industry to the veterinary drug development arena. The documents lay the foundation for consideration of the use of biomarkers, adaptive and other innovative designs, as well as incorporation of real world evidence and data collected in foreign countries to support new animal drug approvals by FDA in the US. However, logistical and statistical challenges to the practical implementation of many of the approaches outlined in the guidance documents exist, and may impede their adoption. Promising potential applications from the guidance documents will be highlighted, and benefits and challenges associated with each discussed, from an industry perspective. Topics addressed will include development and incorporation of biomarkers and surrogate endpoints in clinical trials, enrichment strategies and implications, sample size re-estimation, and use of data from health-sensing devices.