Veterinary oncology clinical trials: Design and implementation

•The application of rigorously executed clinical trials is a relatively new concept in veterinary oncology.•A working understanding of trial design and implementation is important for clinical investigators.•A new era of clinical trials through consortia and cooperative groups is beginning in veterinary oncology.

There has been a recent increase in interest among veterinarians and the larger biomedical community in the evaluation of novel cancer therapies in client-owned (pet) animals with spontaneous cancer. This includes novel drugs designed to be veterinary therapeutics, as well as agents for which data generated in animals with tumors may inform human clinical trial design and implementation. An understanding of the process involved in moving a therapeutic agent through the stages of clinical evaluation is critical to the successful implementation of clinical investigations, as well as interpretation of the veterinary oncology literature. This review outlines considerations in the design and conduct of the various phases of oncology clinical trials, along with recent adaptations/modifications of these basic designs that can enhance the generation of timely and meaningful clinical data.