Ward J M, Hardisty J F, Hailey J R, Streett C S
National Cancer Institute, Frederick, Maryland 21702-1201, USA.
Toxicol Pathol. 1995 Mar-Apr;23(2):226-34. doi: 10.1177/019262339502300218.
Peer review of histopathology findings in safety assessment studies involving rodents and other animals is a relatively recent procedure in toxicologic pathology. It serves to ensure the integrity of the pathology evaluation in safety studies, encourages consistency of diagnostic criteria and use of common terminology, and provides a method of continuing education for participants. The use of a standardized system of pathology nomenclature and diagnostic criteria, such as the Society of Toxicologic Pathologist's Guides for Toxicologic Pathology, is of great value in the procedure. Pathology reviews may involve government-sponsored bioassay programs, in-house industrial corporations, or individual peer reviews suggested or required by government regulatory agencies. Pathology Working Groups can be an integral part of the review process. The extent of the peer review is primarily dependent on the study results; however, other variables such as confidence of the data, study size and duration, complexity, and purpose are also important considerations. Essential components of any peer review, however, include selection of tissues/lesions for review, by a reviewing pathologist, discrepancy resolution, data modification, and documentation of all aspects of the review process. Specific procedures for pathology peer review are discussed. Disagreements among pathologists discovered in peer reviews can be resolved by several methods and examples will be presented. The entire pathology peer review process should be a learning experience for all involved and can help ensure the integrity of animal toxicology studies used for important regulatory decisions involving the use of chemicals in our society.
在涉及啮齿动物和其他动物的安全性评估研究中，对组织病理学结果进行同行评审是毒理病理学中一项相对较新的程序。它有助于确保安全性研究中病理学评估的完整性，鼓励诊断标准的一致性和通用术语的使用，并为参与者提供一种继续教育的方法。在该程序中，使用标准化的病理学命名和诊断标准系统，如毒理病理学家协会的《毒理病理学指南》，具有重要价值。病理学评审可能涉及政府资助的生物测定项目、内部工业公司，或政府监管机构建议或要求的个人同行评审。病理学工作组可以是评审过程中不可或缺的一部分。同行评审的范围主要取决于研究结果；然而，其他变量，如数据的可信度、研究规模和持续时间、复杂性和目的，也是重要的考虑因素。然而，任何同行评审的基本组成部分包括由评审病理学家选择要评审的组织/病变、解决差异、修改数据以及记录评审过程的各个方面。文中讨论了病理学同行评审的具体程序。将介绍在同行评审中发现的病理学家之间的分歧可以通过几种方法解决的实例。整个病理学同行评审过程对所有相关人员都应该是一次学习经历，并且有助于确保用于涉及社会中化学品使用的重要监管决策的动物毒理学研究的完整性。
