在非临床安全研究中实施虚拟控制组
Emily Golden1, David Allen2, Alexander Amberg3
1Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
ALTEX
|December 3, 2023
概括
历史的动物毒性数据可以创建虚拟的对照组,减少安全性研究中的动物使用. 进一步发展需要处理数据管理,统计方法和验证,以确保对人类风险评估的可靠结果.
科学领域:
- 毒理学 毒理学 毒理学
- 动物福利 动物福利
- 监管科学 监管科学
背景情况:
- 动物毒性研究中的历史控制数据主要用于比较分析.
- 这些研究的受控性质表明,有可能使用历史数据来形成虚拟控制组.
- 实施虚拟控制组可以显著减少安全测试中使用的动物数量.
研究的目的:
- 探索利用历史控制数据建立虚拟控制组的可行性和先决条件.
- 确定必要的数据收集,策划,统计评估和验证策略.
- 评估虚拟控制组在取代并发控制和减少动物使用方面的潜力.
主要方法:
- 研讨会召集了来自制药,化学工业,学术界,监管机构 (FDA),CRO和非政府组织的利益相关者.
- 总结了欧洲关于集中共享和管理动物控制数据的倡议.
- 探索了虚拟和治疗组之间的匹配标准和资格策略的初始方法.
主要成果:
- 该报告概述了目前在数据集中和动物控制数据策划方面的努力.
- 确定了用于将虚拟对照匹配到研究治疗臂的初始方法.
- 开始思考与虚拟控制组相关的资格程序和潜在挑战.
结论:
- 虚拟控制组为减少在毒性研究中使用动物提供了一个有希望的途径.
- 仔细考虑数据管理,统计方法和验证对于成功实施至关重要.
- 需要持续的合作和开发来完善该概念,并确保其可靠性用于监管用途.
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