Details
| Original language | English |
|---|---|
| Pages (from-to) | 65-78 |
| Number of pages | 14 |
| Journal | Environmental Biosafety Research |
| Volume | 8 |
| Issue number | 2 |
| Publication status | Published - Apr 2009 |
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.
Keywords
- Environmental risk assessment, Equivalence test, Experimental design, Genetically modified plant, Statistical analysis, Statistical power
ASJC Scopus subject areas
- Biochemistry, Genetics and Molecular Biology(all)
- Biotechnology
- Engineering(all)
- Biomedical Engineering
- Engineering(all)
- Safety, Risk, Reliability and Quality
- Environmental Science(all)
- Agricultural and Biological Sciences(all)
- Social Sciences(all)
- Safety Research
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In: Environmental Biosafety Research, Vol. 8, No. 2, 04.2009, p. 65-78.
Research output: Contribution to journal › Review article › Research › peer review
}
TY - JOUR
T1 - Statistical aspects of environmental risk assessment of GM plants for effects on non-target organisms
AU - Perry, Joe N.
AU - Braak, Cajo J.F.Ter
AU - Dixon, Philip M.
AU - Duan, Jian J.
AU - Hails, Rosie S.
AU - Huesken, Alexandra
AU - Lavielle, Marc
AU - Marvier, Michelle
AU - Scardi, Michele
AU - Schmidt, Kerstin
AU - Tothmeresz, Bela
AU - Schaarschmidt, Frank
AU - Voet, Hilko Van Der
PY - 2009/4
Y1 - 2009/4
N2 - 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.
AB - 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.
KW - Environmental risk assessment
KW - Equivalence test
KW - Experimental design
KW - Genetically modified plant
KW - Statistical analysis
KW - Statistical power
UR - http://www.scopus.com/inward/record.url?scp=70350138493&partnerID=8YFLogxK
U2 - 10.1051/ebr/2009009
DO - 10.1051/ebr/2009009
M3 - Review article
C2 - 19833074
AN - SCOPUS:70350138493
VL - 8
SP - 65
EP - 78
JO - Environmental Biosafety Research
JF - Environmental Biosafety Research
SN - 1635-7922
IS - 2
ER -