Abstract
Response to International Recommendations for Training Future Toxicologic Pathologists Participating in Regulatory-Type, Nonclinical Toxicity Studies by Bolon et. al.
Dear Dr. Foster,
The Clinical Pathology Interest Group of the Society of Toxicologic Pathology (STP) wishes to commend the International Federation of Societies of Toxicologic Pathologists (IFSTP) for proposing training recommendations for future toxicologic pathologists that acknowledge at least the basic role of the clinical pathologist in nonclinical toxicology. The article titled “International Recommendations for Training Future Toxicologic Pathologists Participating in Regulatory-Type, Nonclinical Toxicity Studies” was an ambitious undertaking that understandably required certain concessions based on regional and institutional differences around the world. We are aware that the perception of clinical pathology as a discipline in nonclinical toxicology varies considerably from one country to another and from one institution to another. We believe, however, that countries and institutions that embrace the discipline and take advantage of the special talents and expertise of clinical pathologists produce a superior product with respect to nonclinical toxicity study assessment and also afford themselves additional capabilities not readily attained by other means.
With these thoughts in mind, we would like to share two simple comments concerning the article and the practice of toxicologic pathology. First, while we recognize the skills and tools used in training toxicologic pathologists listed in Table 3 are said to “represent a minimum approach,” they understate the skills and tools actually used by clinical pathologists. It is important to emphasize that clinical pathologists serve in a variety of other roles such as laboratory management, instrument and method validation, biomarker development, animal model development, quality control, study design (basic and mechanistic), program design, data integration, translational medicine, and animal colony health. Second, although we understand this was not the purpose of the article, we believe the optimal practice of toxicologic pathology with respect to regulatory-type, nonclinical toxicity studies draws on the knowledge and skills of anatomic and clinical pathologists working together. It may be less expensive and more expedient for one pathologist to serve multiple roles, but it is not better and certainly not the best. We encourage the IFSTP to continue to include and identify clinical pathologists in guidance and regulatory documents to embrace the expertise, energy, and value they contribute to the safety assessment process and field of toxicologic pathology.