Clinical Study Costs (Target Animal Safety and Efficacy): The cost of conducting a veterinary clinical studies can range from several thousand dollars to several hundred thousand dollars. Veterinary study costs are often broken down into fixed and variable expenses. Fixed costs can include site fees, document preparation, monitoring fees, data tabulation, and report generation while variable costs are often directly associated with patient procedures. Veterinary clinical study costs are often influenced by several factors, including but not limited to:
Study Conditions: non-GCP, GCP or GLP. Proof of concept studies may often involved only a few number of subjects (10-30), and are often performed under non-GCP conditions. Pivotal studies that are used to support a products approval are most commonly performed under GCP or GLP conditions, and are typically more expensive owing to the degree of documentaiotn and QA/QC involved in these studies.
Duration: The duration of a veterinary clinical study can vary, from days to years, depending on the investigational product being evaluated. For instance, a product that may only be used for acute and critical care situations or that may only be used once can often be evaluated over a few days. Other products that are anticipated to be used frequently over extended periods of time are often studied for months or longer.
Number of Subjects: Pilot studies often involve only a few number of veterinary patients, so the patient specific costs are often lower to complete the study. Confirmatory studies (safety and efficacy) may require a larger number of patients, sometimes several hundred patients.
Outcomes for Assessment: The outcomes for assessment often drive the information which will be used to evidence safety or efficacy. There are a variety of subjective and objective data that can be obtained through physical exams, bloodwork, special diagnostics, imaging, etc.
What is the total cost of developing a new animal drug or new animal biologic? to obtain an approval for a new veterinary drug or veterinary biologic in the United States, it may take 4-6 years of development work and cost between $3-7 million dollars. The costs include not just the clinical studies, but may also reflect the costs to satisfy the additional technical sections of the veterinary drug development or veterinary biologics approval process.