Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology

Area of Science:

• Toxicology
• Genomics
• Metabolomics
• Bioinformatics

Background:

• Omics methodologies are crucial for understanding toxicity mechanisms and are increasingly applied to regulatory toxicology questions.
• Despite their utility, omics data face barriers to regulatory acceptance, including lack of transparency in data processing and inconsistent reporting standards.
• These limitations hinder the routine application of omics data in regulatory decision-making.

Purpose of the Study:

• To address the barriers hindering regulatory acceptance of omics data.
• To develop a formal reporting framework for omics data processing and analysis in regulatory toxicology.
• To foster wider regulatory use of transcriptomic and metabolomic data.

Main Methods:

• The Organisation for Economic Co-operation and Development (OECD) Extended Advisory Group on Molecular Screening and Toxicogenomics (EAGMST) initiated a project in 2017.
• Development of a modular reporting framework for transcriptomic and metabolomic data.
• Focus on data processing, analysis, content harmonization, and a strategy for pre-publication trialling.

Main Results:

• Ongoing development of the first formal reporting framework for omics data in regulatory toxicology.
• The framework addresses transparency and standardization issues in data processing and reporting.
• The framework is designed to be modular, comprehensive, and harmonized.

Conclusions:

• A standardized reporting framework is essential for the regulatory acceptance of omics data.
• The OECD project aims to provide clear guidance for reporting omics data, facilitating its use in regulatory toxicology.
• Successful implementation of this framework is expected to enhance the reliability and interpretability of omics data for regulatory purposes.