title: Veterinary oncology clinical trials: design and implementation.
abstract: 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.
authors.affiliation: Flint Animal Cancer Center, Colorado State University, 300 West Drake Road, Fort Collins, CO 80523-1620, USA. Electronic address: dthamm@colostate.edu.
authors.forename: Douglas H
authors.initials: DH
authors.lastname: Thamm
authors.affiliation: Barbara Suran Comparative Oncology Program, School of Veterinary Medicine, University of Wisconsin, 2015 Linden Drive, Madison, WI 53706, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Vail
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000662:veterinary*; D009369:Neoplasms / Q000188:drug therapy / Q000662:veterinary*; D012107:Research Design
chemical_list: D000970:Antineoplastic Agents
keywords: Canine; Clinical trial; Oncology; Therapeutic agents; Tumor