Mission Statement

The Clinical Trials Office (CTO) provides assistance in the design, execution, and evaluation of veterinary clinical trials using client-owned animals, with the overriding goal of advancing the diagnosis and treatment of disease in veterinary patients.

Responsibilities of the CTO include:

• providing guidance with respect to clinical trial design including: formulation of a testable hypothesis; determination of patient entry criteria; selection of appropriate toxicity assessments; review of appropriate statistical end points; development of an accurate budget
• confirming compliance with applicable hospital, IRB, and/or IACUC requirements
• assisting with a risk assessment to determine the likelihood of adverse events
• reviewing proposals prior to presentation to Hospital Executive Committee
• establishing and maintaining a network of regional specialists, veterinarians, and breed clubs to assist with patient enrollment
• providing education in GCP, GLP, and the requirements of individual organizations sponsoring trials
• overseeing and verifying correct and complete data entry, as well as compliance with established study guidelines

Responsibilities of the Principle Investigator include:

• providing the CTO with a proposal for which appropriate statistical analysis has been included
• providing the CTO with a proposal containing an accurate budget that includes all relevant direct and indirect costs
• addressing all potential adverse events and providing appropriate budgetary support should these occur
• completing appropriate IRB and IACUC forms prior to evaluation by the Hospital Executive Committee
• ensuring that patients entered into clinical trials meet inclusion criteria
• obtaining client consent and maintaining client contact as needed
• performing actual data entry and sample collection as specified in the study guidelines
• performing final analysis upon study completion