Abstract
We are a small but dedicated group of certified veterinary clinical pathologists. We are familiar with the practice of toxicologic clinical pathology in the industry in North America and Europe. We have read and discussed the manuscript titled “International Recommendations for Training Future Toxicologic Pathologists Participating in Regulatory-Type, Nonclinical Toxicity Studies.” On behalf of the European College of Veterinary Clinical Pathology, a European Board for Veterinary Specialization (EBVS)–recognized specialty college for clinical pathology in Europe, we would like to present our unanimous considered opinion on the two main issues that are of concern to us in your article.
Issue 1: Requirement for a degree in veterinary medicine for specialized pathologists working in preclinical sciences
Issue 2: Role of veterinary clinical pathologists in the industry
Based on our collective experience, we strongly feel that a degree in veterinary medicine should be mandatory for professionals specializing in toxicologic pathology (anatomic or clinical). We are aware of historical and cultural reasons for individuals with variable nonveterinary backgrounds to take on responsibilities as pathologists in toxicology. We also fully acknowledge that numerous nonveterinarians are currently doing excellent work in interpreting preclinical study data. However, for future guidelines on best practices, we urge the industry to be aware of evolving trends in preclinical sciences that will require highly qualified veterinary specialists such as certified veterinary clinical pathologists. In our experience, veterinary clinical pathology, a discipline based on a thorough understanding of internal medicine, provides a very important link between preclinical sciences and clinical safety study design.
We would like to emphasize the different roles of a veterinary clinical pathologist in toxicology that go beyond just the data interpretation of preclinical studies, whether this includes all data generated in a study or just laboratory data (Schultze, Bounous, and Provencher Bolliger 2008). Importantly, there are some unique areas of expertise in veterinary clinical pathology that are not covered in specialized training programs in anatomic pathology. These include all aspects relating to laboratory management and actual laboratory data generation, activities that take place prior to actual data analysis. Specifically, clinical pathologists have the necessary expertise for method and instrument validation, daily and long-term quality control, and hence the understanding of the importance of statistical significance of apparent differences, be they treatment related or not. Furthermore, laboratory management is an important and mandatory part of the training of clinical pathology residents. Finally, based on a profound understanding of pathophysiological processes, veterinary clinical pathologists are in a unique position to develop and establish tests for and understand the relevance of new biomarkers to be introduced in preclinical sciences in the future.
We hope that with our short analysis focused on these two main points, we can contribute to a better understanding and an increased recognition of veterinary clinical pathology as a specialty in toxicology. This initiative is led by the two well-established veterinary specialty colleges in Europe and United States, both of which enjoy a strong reputation for tradition and high-quality standards. We feel that high-quality training and examination standards for future veterinary clinical pathologists will also guarantee the development of valued professionals in toxicology. Whether a subspecialty of toxicologic clinical pathology should or could be envisioned within our college would need to be clarified by the EBVS and its counterpart in the United States (American Board of Veterinary Specialties). Further specific recommendations are expected to be provided by the American Society for Veterinary Clinical Pathology (Best Practices in Veterinary Clinical Pathology in the Pharmaceutical Industry) in the near future.
This letter will also be published in the Journal of Toxicologic Pathology (Japanese Society of Toxicologic Pathology) and in the Journal of Experimental and Toxicologic Pathology (European Society of Toxicologic Pathology).