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Regul Toxicol Pharmacol. 2020 Jun;113:104639. doi: 10.1016/j.yrtph.2020.104639. Epub 2020 Mar 5.
In 2019, the International Agency for Research on Cancer (IARC) "Preamble to the IARC Monographs" expanded guidance regarding the scientific approaches that should be employed in its monographs. These amendments to the monograph development process are an improvement but still fall short in several areas. While the revised Preamble lays out broad methods and approaches to evaluate scientific evidence, there is a lack of specificity with regard to how IARC Working Groups will conduct consistent evaluations in a standardized, objective, and transparent manner; document systematic review and evidence integration actions, and substantiate how these actions and decisions inform the ultimate classifications. Furthermore, no guidance is provided to ensure Working Groups consistently incorporate mechanistic evidence in a robust manner using a defined approach in the context of 21st century knowledge of modes of action. Nor are the conclusions of the working groups subjected to outside, independent scientific peer review. Continued improvements and modernization of the procedures for evaluating, presenting, and communicating study quality, and in the methods used to conduct and peer-review evidence-based decision making will benefit the Working Group members, the IARC Monographs Programme overall, and the international regulatory community and public who rely upon the monographs.
2019 年，国际癌症研究机构（IARC）在“《IARC 专论》前言”中扩大了其专论中应采用的科学方法的指导。对专论制定过程的这些修订是一种改进，但在几个方面仍有不足。虽然修订后的前言为评估科学证据制定了广泛的方法和途径，但在 IARC 工作组将如何以标准化、客观和透明的方式进行一致评估、记录系统评价和证据综合行动，以及说明这些行动和决策如何为最终分类提供信息方面，缺乏具体性。此外，没有提供指导以确保工作组始终以稳健的方式使用既定方法，将机制证据纳入 21 世纪对作用模式的了解之中。工作组的结论也没有接受外部独立的科学同行评审。不断改进和现代化评估、呈现和交流研究质量的程序，以及用于开展和同行评审循证决策的方法，将使工作组的成员、IARC 专论计划整体以及依赖专论的国际监管界和公众受益。
