Development of effective and safe treatments for companion animals with cancer requires the collaboration of numerous animal health professionals and the full engagement of animal owners. Establishing ‘Best Practice Recommendations’ for clinical trials in veterinary oncology represents an important step toward meeting the goal of rigorous clinical trial design and conduct that is required to establish valid evidence. Likewise, optimizing patient welfare and owner education and advocacy is crucial to meet the unique ethical obligations to both owners and animals enrolled in these clinical trials and to ensure trust in the team conducting the research. To date, ‘Best Practice Recommendations’ for clinical trial conduct have not been reported for veterinary oncology. This document summarizes the consensus of a workshop held in November, 2014 to identify relevant ethical principles and to ensure responsible conduct of clinical research in companion animals with cancer. It is intended as a working document that will be updated as advances in science and ethical considerations require. To the extent possible, existing guidelines for the conduct and oversight of clinical trials in humans have been adapted for veterinary trials to avoid duplicative effort and to facilitate integration of clinical trials such that translational research with benefits for both companion animals and humans are encouraged.

BackgroundStudying cancer and other diseases poses a problem due to their protracted and multifactorial nature. Prospective studies are useful to investigate chronic disease processes since collection of lifestyle information, exposure data and co-incident health issues are collected before the condition manifests. The Golden Retriever Lifetime Study is one of the first prospective studies following privately-owned dogs throughout life to investigate the incidence and risk factors for disease outcomes, especially cancer.Owners of golden retrievers in the contiguous United States volunteered their dogs in early life. Owners and veterinarians complete online questionnaires about health status and lifestyle; dogs undergo a physical examination and collection of biological samples annually. The data presented summarize the initial study visits and the corresponding questionnaires for 3044 dogs in the cohort.ResultsThe median age of dogs at enrollment was 14.0 months (interquartile range (IQR): 8–20 months). Approximately half of the population had undergone gonadectomy by their initial study visit. Medical conditions reported at enrollment consisted primarily of integumentary, gastrointestinal and urinary dysfunction. A large majority of the dogs have a record of having received preventive care (vaccines, parasiticides, flea and heartworm prevention) by the time of the initial study visit. Clinical pathology data were unremarkable.ConclusionsThis study represents one of the first lifetime observational investigations in veterinary medicine. The population characteristics reported here indicate a healthy cohort of golden retrievers cared for by owners committed to their dogs’ health. Data acquired over the study period will provide valuable information about genetic, dietary and environmental risk factors associated with disease in golden retrievers and a framework for future prospective studies in veterinary medicine.Electronic supplementary materialThe online version of this article (10.1186/s40575-017-0053-5) contains supplementary material, which is available to authorized users.

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Background: Annual wellness testing is widely recommended for apparently healthy dogs, but there is little data to assist with distinguishing normal variation from clinically important changes. Objectives: To define variability in biochemistry analytes between annual wellness tests in healthy Golden Retrievers. Animals: Four hundred thirty-four Golden Retrievers undergoing annual health assessments by their primary care veterinarians as part of a prospective cohort study. Methods: Changes in 23 biochemistry analytes were calculated between year 1 and year 2 health checks for 196 dogs classified as healthy for ≥3 consecutive years. Using a direct nonparametric method, annual change intervals were constructed to define normal variability. A validation cohort of 238 dogs without a diagnosis of systemic disease for ≥3 consecutive years were compared with the reference and annual change intervals, and the proportions of dogs outside annual change intervals and a population-based reference interval were compared by using a McNemar test. Results: Annual change intervals were calculated based on 190 dogs after outlier removal. For all 23 analytes, >90% of dogs in the validation cohort were within the annual change interval. There were no significant differences in the classification by reference versus annual change intervals. Conclusions and Clinical Importance: The annual change intervals met performance requirements for classification of dogs that did not develop systemic disease in the year following wellness testing as normal.