在非临床安全性研究中实施虚拟控制组。

IF 4.5 2区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 Epub Date: 2023-12-01 DOI:10.14573/altex.2310041
Emily Golden, David Allen, Alexander Amberg, Lennart T Anger, Elizabeth Baker, Szczepan W Baran, Frank Bringezu, Matthew Clark, Guillemette Duchateau-Nguyen, Sylvia E Escher, Varun Giri, Armelle Grevot, Thomas Hartung, Dingzhou Li, Laura Lotfi, Wolfgang Muster, Kevin Snyder, Ronald Wange, Thomas Steger-Hartmann
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引用次数: 0

摘要

动物毒性研究中对照组的历史数据目前主要用于比较目的,以评估研究结果的有效性和稳健性。由于进行研究的高度受控环境和动物群体的同质性,有人建议使用历史数据来建立所谓的虚拟控制组,这可以部分或完全取代并行控制。这将对减少安全性研究中的动物使用作出重大贡献。在实施该概念之前,需要确定有关数据收集、管理和统计评估以及验证策略的先决条件,以避免对研究结果的任何损害以及对人类风险评估的后续后果。为了进一步评估和发展虚拟控制组的概念,跨大西洋毒理学智库(t⁴)于2023年3月在华盛顿主办了一次研讨会,与会者包括来自制药和化学工业、学术界、FDA、制药、合同研究组织(cro)和非政府组织的利益相关者。本报告总结了欧洲在中央数据库中共享、收集和整理动物控制数据的举措,以及确定虚拟对照和研究治疗组之间最佳匹配标准的初步方法,以及对资格程序策略的初步思考和该概念的潜在缺陷。
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Toward implementing virtual control groups in nonclinical safety studies.

Historical data from control groups in animal toxicity studies are currently mainly used for comparative purposes to assess validity and robustness of study results. Due to the highly controlled environment in which the studies are performed and the homogeneity of the animal collectives it has been proposed to use the historical data to build so-called virtual control groups, which could partly or entirely replace the concurrent control group. This would constitute a substantial contribution to the reduction of animal use in safety studies. Before the concept can be implemented, the prerequisites regarding data collection, curation, and statistical evaluation together with a validation strategy need to be identified to avoid any impairment of the study outcome and subsequent consequences for human risk assessment. To further assess and develop the concept of virtual control groups, the transatlantic think tank for toxicology (t4) sponsored a workshop with stakeholders from the phar­maceutical and chemical industry, academia, FDA, contract research organizations (CROs), and non-governmental organizations in Washington, which took place in March 2023. This report sum­marizes the current efforts of a European initiative to share, collect, and curate animal control data in a centralized database and the first approaches to identify optimal matching criteria between virtual controls and the treatment arms of a study as well as first reflections about strategies for a qualifi­cation procedure and potential pitfalls of the concept.

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来源期刊
Altex-Alternatives To Animal Experimentation
Altex-Alternatives To Animal Experimentation MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
7.70
自引率
8.90%
发文量
89
审稿时长
2 months
期刊介绍: ALTEX publishes original articles, short communications, reviews, as well as news and comments and meeting reports. Manuscripts submitted to ALTEX are evaluated by two expert reviewers. The evaluation takes into account the scientific merit of a manuscript and its contribution to animal welfare and the 3R principle.
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