Perry Joe N, Ter Braak Cajo J F, Dixon Philip M, Duan Jian J, Hails Rosie S, Huesken Alexandra, Lavielle Marc, Marvier Michelle, Scardi Michele, Schmidt Kerstin, Tothmeresz Bela, Schaarschmidt Frank, van der Voet Hilko
Oaklands Barn, Lug's Lane, Broome, Norfolk, UK.
Environ Biosafety Res. 2009 Apr-Jun;8(2):65-78. doi: 10.1051/ebr/2009009. Epub 2009 Oct 16.
Previous European guidance for environmental risk assessment of genetically modified plants emphasized the concepts of statistical power but provided no explicit requirements for the provision of statistical power analyses. Similarly, whilst the need for good experimental designs was stressed, no minimum guidelines were set for replication or sample sizes. Furthermore, although substantial equivalence was stressed as central to risk assessment, no means of quantification of this concept was given. This paper suggests several ways in which existing guidance might be revised to address these problems. One approach explored is the ;bioequivalence' test, which has the advantage that the error of most concern to the consumer may be set relatively easily. Also, since the burden of proof is placed on the experimenter, the test promotes high-quality, well-replicated experiments with sufficient statistical power. Other recommendations cover the specification of effect sizes, the choice of appropriate comparators, the use of positive controls, meta-analyses, multivariate analysis and diversity indices. Specific guidance is suggested for experimental designs of field trials and their statistical analyses. A checklist for experimental design is proposed to accompany all environmental risk assessments.
先前欧洲关于转基因植物环境风险评估的指南强调了统计功效的概念，但未对提供统计功效分析提出明确要求。同样，虽然强调了良好实验设计的必要性，但未对重复或样本量设定最低指导原则。此外，尽管强调实质等同性是风险评估的核心，但未给出量化这一概念的方法。本文提出了几种修订现有指南以解决这些问题的方法。探讨的一种方法是“生物等效性”测试，其优点是可以相对容易地设定消费者最关注的误差。此外，由于举证责任在于实验者，该测试促进了具有足够统计功效的高质量、重复良好的实验。其他建议包括效应大小的规范、合适对照物的选择、阳性对照的使用、荟萃分析、多变量分析和多样性指数。针对田间试验的实验设计及其统计分析提出了具体指导。建议为所有环境风险评估配备一份实验设计清单。
