Veterinary Clinical Studies: Managing Expectations

Clinical studies are a vital component of development and regulatory approval of veterinary medicines for the global marketplace. Success in obtaining authorisation to market a product is dependent upon demonstration that the product will work (efficacy) and will do no harm (safety), in the target population and under the conditions of intended use. In contrast to research-phase studies, which may provide a “reasonable expectation” of safety and efficacy, clinical studies for regulatory submission must “establish” safety and efficacy. This is accomplished in large part through valid study design documented in a comprehensive protocol. Generation of a high-quality protocol, however, is just one aspect of meeting the stringent regulatory requirements for establishment of product safety and efficacy. Follow-through is essential to provide assurance that the study is conducted according to the protocol, and ensure that the data collected are acceptable to the regulators.