Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review

Gbeminiyi O. Samuel, Sebastian Hoffmann, Robert A. Wright, Manoj Mathew Lalu, Grace Patlewicz, Richard A. Becker, George L. DeGeorge, Dean Fergusson, Thomas Hartung, R. Jeffrey Lewis, Martin L. Stephens

Research output: Contribution to journalArticlepeer-review


Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias – as in clinical medicine and healthcare – or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work.

Original languageEnglish (US)
Pages (from-to)630-646
Number of pages17
JournalEnvironment international
StatePublished - Jul 1 2016


  • Methodological quality
  • Reporting quality
  • Risk of bias
  • Scoping review
  • Toxicity studies

ASJC Scopus subject areas

  • Environmental Science(all)


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