设计INVITES-IN的协议,用于评估体外研究的内部有效性
Camilla Svendsen1,2, Paul Whaley1,3, Gunn E Vist1,4
1Norwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
概括
一个新的工具,INVITES-IN (体外实验研究内部有效性) 正在开发,以评估体外研究的内部有效性. 这将提高在系统审查和化学风险评估中使用的证据的可靠性.
科学领域:
- 毒理学和药理学 毒理学和药理学
- 生物医学研究方法学
背景情况:
- 对体外研究进行严格的评估对于将其纳入系统性审查和化学风险评估至关重要.
- 现有的方法可能无法充分捕捉细胞培养研究的内部有效性的细微差别,包括使用新方法方法 (NAM) 的研究.
研究的目的:
- 描述INVITES-IN (体外实验研究内部有效性) 的设计和开发协议,这是评估体外研究内部有效性的新工具.
- 概述初步研究的重点是确定相关的偏差领域和用于体外研究评估的项目.
主要方法:
- 研究1:现有评估工具的综合评估与重点小组讨论,以确定影响体外研究内部有效性的因素.
- 研究2:修改了Delphi方法,以在关键的内部有效性领域和体外研究项目上达成群体共识.
- 研究3:基于研究1和研究2的发现,创建INVITES-IN工具的版本草案.
主要成果:
- 通过专家咨询和文献审查,确定与体外研究内部有效性相关的关键偏差领域和项目.
- 建立关于特定领域和项目对评估体外研究质量的重要性的共识.
- 开发INVITES-IN工具的版本草案,为用户测试和验证奠定基础.
结论:
- 该协议概述了开发INVITES-IN的系统方法,这是一个专门用于评估体外研究内部有效性的工具.
- 该工具旨在提高从体外数据中获得的证据的质量和可靠性,用于监管科学和研究综合.
- 计划进行进一步的研究,以进行用户测试和验证,以确保该工具的实际实用性和有效性.
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