组织病理学同行评议病理工作组简介

Brief Introduction of Pathology Working Group for Peer Review of Histopathology

毒性病理学是药物非临床安全性评价的重要组成部分,组织病理学同行评议可保证病理诊断术语的一致性、准确性以及病理诊断的完整性,提高病理解释的准确性和病理报告的质量,通过评议所有的靶器官,确认无作用剂量及无可见不良作用剂量。同行评议过程中专题病理学家和评议病理学家通过比较结果以解决意见分歧,对靶器官、给药相关病变术语、给药相关病变的剂量组以及专题病理学家病理报告的主要结论达成共识。如果专题病理学家和同行评议病理学家通过非正式咨询第三方病理学家后不能达成共识,可通过正式组建病理工作组解决意见分歧。病理学工作组是评议的一种特殊形式,由病理学专家组成,对有关实验结果的具体问题提供一个独立、公正的评估,回答监管部门的问题,或比较多个不同实验室开展和/或病理学家评价的多个实验的结果,病理工作组的结果和结论通常正式记录在病理工作组报告中。本文简要介绍了组织病理学同行评议中病理工作组相关指导原则、病理工作组的目的、病理工作组审阅的内容、病理工作组可解决的问题、病理工作组组长和组员的职责、病理工作组报告等内容,以期为我国药物毒理学非临床安全性评价领域更好地利用病理工作组开展组织病理学同行评议提供一些参考。

Toxicologic pathology is an important part of the nonclinical safety evaluation of drugs. Peer review of histopathology can ensure accuracy and consistency of nomenclature and diagnosis completeness, improve the accuracy of pathology interpretation and the quality of pathology report, determine the appropriateness of the NOEL and NOAEL by reviewing all target organs. Study pathologist and peer-review pathologist should compare their results to resolve the differences of opinion and should reach consensus on target organs, terminology of treatment-related findings, dose groups of treatment-related findings, and other major conclusions in the study pathologist＇s report through discussion during the peer review. If study pathologist and peer-review pathologistcannot reach agreement through informal consultation of third pathologist, a formal pathology working group（PWG） may be established to resolve the differences. PWG is a specialized form of review, consisting of a panel of pathology experts, which may provide an independent, unbiased assessment for specific questions concerning study results, address questions of regulatory agency, or compare the results of multiple studies conducted and evaluated by different laboratories and/or pathologists. The results and conclusions of PWG are normally formal and reflected in a PWG report. The PWG for peer review of histopathology, including relevant guidelines, objectives of PWG, material reviewed by PWG, issues addressed by PWG, responsibilities of chairperson and members of PWG, and PWG report was briefly introduced to provide some references for the application of PWG to conduct peer review of histopathology during nonclinical safety evaluation of drugs in China.