Conducting Clinical Trials in Practice

摘要

Clinical field trials are a critical component of most new animal drug approvals because they provide important information on the safety and efficacy of a new drug product under real-world conditions. Many practitioners find participating in clinicaltrials rewarding both intellectually and financially, but they present different challenges from those of typical daily clinical practice. Veterinarians need to understand these challenges and the expectations of the various stakeholders involved in theclinical trial (drug sponsor, regulatory agency, pet owner). It is also important to understand what obligations the stakeholders have to the veterinarians conducting the trial. This lecture will focus on clinical field trials for companion animal products regulated by the FDA-CVM, but the general concepts can be applied to studies for USDA-reguIated products. By understanding the expectations of the clinical trial from the perspective of the sponsor and the regulatory authorities, veterinarians can make informed choices regarding which trials in which to participate, so they and their patients can derive maximum benefit, while providing timely and accurate data to the drug sponsor regarding the safety and efficacy of a new animal drug.