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Progress Towards an OECD Reporting Framework for Transcriptomics and Metabolomics in Regulatory Toxicology
Citation:
Harrill, J., M. Viant, C. Yauk, M. Sachana, T. Gant, S. Auerbach, R. Beger, M. Bouhifd, J. O'Brien, L. Burgoon, F. Caiment, D. Carpi, T. Chen, B. Chorley, J. Colbourne, R. Corvi, L. Debrauwer, C. O'Donovan, T. Ebbels, D. Ekman, F. Faulhammer, L. Gribaldo, G. Hilton, S. Jones, A. Kende, T. Lawson, S. Leite, P. Leonards, M. Luijten, A. Martin, L. Moussa, S. Rudaz, O. Schmitz, T. Sobanski, V. Strauss, M. Vaccari, V. Vijay, R. Weber, A. Williams, A. Williams, R. Thomas, AND M. Whelan. Progress Towards an OECD Reporting Framework for Transcriptomics and Metabolomics in Regulatory Toxicology. REGULATORY TOXICOLOGY AND PHARMACOLOGY. Elsevier Science Ltd, New York, NY, 125:105020, (2021). https://doi.org/10.1016/j.yrtph.2021.105020
Impact/Purpose:
The Organization for Economic Cooperation and Development (OECD) Extended Advisory Group for Molecular Screening and Toxicogenomics (EAGMST) initiated a project aimed at developing a reporting framework for omics toxicology studies to promote regulatory acceptance and use of omics data in risk assessment applications. This manuscript is a commentary that describes progress towards development of this omics reporting framework. The manuscript is a forerunner to final review and release of the omics reporting framework by OECD.
Description:
Omics methodologies are widely used in toxicological research to understand modes and mechanisms of toxicity. Increasingly, these methodologies are being applied to questions of regulatory interest such as molecular point-of-departure derivation and chemical grouping/read-across. Despite its value, widespread regulatory acceptance of omics data has not yet occurred. Barriers to the routine application of omics data in regulatory decision making have been: 1) lack of transparency for data processing methods used to convert raw data into an interpretable list of observations; and 2) lack of standardization in reporting to ensure that omics data, associated metadata and the methodologies used to generate results are available for review by stakeholders, including regulators. Thus, in 2017, the Organisation for Economic Co-operation and Development (OECD) Extended Advisory Group on Molecular Screening and Toxicogenomics (EAGMST) launched a project to develop guidance for the reporting of omics data aimed at fostering further regulatory use. Here, we report on the ongoing development of the first formal reporting framework describing the processing and analysis of both transcriptomic and metabolomic data for regulatory toxicology. We introduce the modular structure, content, harmonization and strategy for trialling this reporting framework prior to its publication by the OECD.
URLs/Downloads:
DOI: Progress Towards an OECD Reporting Framework for Transcriptomics and Metabolomics in Regulatory Toxicology
https://pubmed.ncbi.nlm.nih.gov/34333066/