Campus Units

Statistics

Document Type

Article

Publication Version

Published Version

Publication Date

2009

Journal or Book Title

Environmental Biosafety Research

Volume

8

Issue

2

First Page

65

Last Page

78

DOI

10.1051/ebr/2009009

Abstract

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.

Comments

This is an article from Environmental Biosafety Research 8 (2009): 65, doi:10.1051/ebr/2009009. Posted with permission.

Rights

Works produced by employees of the U.S. Government as part of their official duties are not copyrighted within the U.S. The content of this document is not copyrighted.

Language

en

File Format

application/pdf

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