ABSTRACT
“Spontaneous model” has become a catchphrase for a study of an investigational intervention (e.g., a drug or procedure), performed in companion animals with naturally occurring disease, that may serve basic research and inform applications in human medicine as well as meet the need for applied knowledge in animal health. There are studies for which risks can be mitigated and studies involving “spontaneous models” that may be advantageous over traditional animal models. A primary purpose of addressing a research question in animals with spontaneous disease is to better understand the biological and/or clinical outcome(s) of exposure to an investigational therapy, product, procedure, or intervention; or to characterize the natural history of a disease. This chapter provides approaches for consideration by Sponsors to describe the study conduct standard in setting of non-GCP that may be appropriate for studies of spontaneous disease in pets.
