高级授粉者研究的统计分析的同等性测试方法 - - 建议和挑战
D Poursina1, E Collison2, S Kimmel3
1Corteva Agriscience, Indianapolis, IN, United States.
Integrated environmental assessment and management
|January 27, 2026
概括
欧洲食品安全局 (EFSA) 关于蜜蜂风险评估的新指南要求蜜蜂研究的复制量比以前想象的要多. 统计模型表明,达到80%的功率来确认低风险需要比当前指南建议的复制量要高得多.
科学领域:
- 生态毒理学 生态毒理学
- 环境科学 环境科学
- 农业科学 农业科学
背景情况:
- 欧洲食品安全局 (EFSA) 修订了其2023年关于评估植物保护产品对蜜蜂的风险指南.
- 一个关键的变化涉及从差异测试转向对更高层次研究的等效测试.
- 这就需要重新评估在半场研究中评估蜜蜂群强度的统计模型.
研究的目的:
- 评估蜜蜂群强度终点等价性测试的统计模型.
- 为了确定复制水平,需要得出结论低风险的物质与<10%真正的殖民地强度减少.
- 探索研究设计修改以减少复制需求.
主要方法:
- 统计模型的比较:t-试验,双向ANOVA和具有自回归 (AR) 结构的线性混合效应模型.
- 模拟各种场景,以评估模型性能和功率.
- 在不同的真实效应大小和研究设计下对复制需求的评估.
主要成果:
- 线性混合效应模型与AR结构和基线调整显示了最高的统计能力.
- 为了达到80%的权力来得出同等性结论,所需的复制次数要远远高于欧洲检察官办公室 (2010) 准则的最低三次.
- 样本大小从7个复制品 (零效应) 到612个复制品 (9%的减少).
- 增加时间相关性提高了功率,减少了复制需求,同时减少了殖民地间的变异性对影响最小.
结论:
- 关于蜜蜂半田间研究的同等性测试的现行EFSA指南可能需要比标准指南建议的复制量要多得多.
- 需要仔细考虑对监管等价性所需的大量复制品进行研究的可行性.
- 进一步了解和潜在的研究设计调整是必要的,以便在蜜蜂保护的监管风险评估中实践实施同等性测试.
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