Abstract
This chapter discusses standards for veterinary clinical trials. A clinical trial is a prospective study that compares the effect(s) and value(s) of an intervention. Although the clinical trial is the most effective method for establishing the effects (efficacy or safety) of an intervention, proper planning and execution are paramount to its success and validity. The groundwork for high-quality clinical trials is laid by observational studies that focus on new or existing interventions and provide the baseline data for these trials. Unlike human clinical trials, the subject of a veterinary clinical trial may be owned by the research facility (experimental) or may be a client-owned patient. It is important to distinguish the source of experimental subjects for a veterinary clinical trial as certain types of bias can be more easily minimized when using experimental animals. Because subject variability (for example, differences due to age, breed, sex, diet, environment, or disease) can be more easily standardized, some investigators do not consider studies that use experimental animals as clinical trials.
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