@article{JRC126197, address = {SAN DIEGO (USA)}, year = {2021}, author = {Harrill JA and Viant MR and Yauk C and Magdalini S and Gant TW and Auerbach SS and Beger RD and Bouhifd M and O’brien J and Burgoon L and Caiment F and Carpi D and Chen T and Chorley BN and Colbourne J and Corvi R and Debrauwer L and O’donovan C and Ebbels T and Ekman DR and Faulhammer F and Gribaldo L and Hilton G and Jones SP and Kende A and Lawson TN and Batista Leite S and Leonards P and Luijten M and Martin A and Moussa L and Rudaz S and Schmitz O and Sobanski T and Strauss V and Vaccari M and Vijay V and Weber R and Williams AJ and Williams A and Russell S. T and Whelan M}, abstract = {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. }, title = {Progress Towards an OECD Reporting Framework for Transcriptomics and Metabolomics in Regulatory Toxicology}, type = {Full paper}, url = {https://www.sciencedirect.com/science/article/pii/S0273230021001616}, volume = {125}, number = {}, journal = {REGULATORY TOXICOLOGY AND PHARMACOLOGY}, pages = {105020}, issn = {0273-2300 (online)}, publisher = {ACADEMIC PRESS INC ELSEVIER SCIENCE}, doi = {10.1016/j.yrtph.2021.105020 (online)