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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
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