Abstract

SummaryFollowing a fundamental statement made in 2016 by the American Statistical Associations and broad and consistent changes in data analysis and interpretation methodology in public health and other sciences, statistical significance/null hypothesis testing is being increasingly criticized and abandoned in the reporting and interpretation of the results of biomedical research. This shift in favor of a more comprehensive and non-dichotomous approach in the assessment of causal relationships may have a major impact on human health risk assessment. It is interesting to see, however, that authoritative opinions by the Supreme Court of the United States and European regulatory agencies have somehow anticipated this tide of criticism of statistical significance testing, thus providing additional support to its demise. Current methodological evidence further warrants abandoning this approach in both the biomedical and public law contexts, in favor of a more comprehensive and flexible method of assessing the effects of toxicological exposure on human and environmental health.

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