New Assessment Methods in regulatory toxicology: development of methodology for the use of meta-analysis of in vivo studies and integration of data from different data streams.
The field or toxicology is in rapid development. Moving from a strong dependency on animal studies there is societal pressure to include and use data from epidemiological studies, in vitro data, systematic literature review, read-across, adverse outcome pathways and other New Assessment Methods in the hazard evaluation of chemicals. NIPH is co-leading a project together with the John Hopkins University in Baltimore and the Evidence Based Toxicology Collaboration (EBTC) in which some of these methods were used and two major challenges were identified:
- When performing a systematic literature study on toxicological studies on specific chemicals many small in vivo studies were identified. There is a need to develop methods to perform a meta-analysis on the data extracted, taking into account different test species, different dose levels and different treatment times
- For some chemicals both in vivo, in vitro and epidemiological data are available. How to integrate data from different evidence streams to reach an overall conclusion is challenging
The aim of this project is to develop easy to use methodology to perform meta-analysis on in vivo toxicological data and to develop a framework for integration of data from different evidence streams. The developed methodology will be used
on a data rich chemical compound for demonstration purposes
- Perform a systematic literature review on methods for meta-analysis of toxicological in vivo data and prepare a short overview.
- Perform a systematic literature review on approaches for data integration used in toxicology and prepare a short overview.
- Critically evaluate the identified methods and identify areas for improvement.
- Develop an easy to use methodology for meta-analysis and data integration.
- Test the selected and developed methods out on a data rich chemical compound and compare with traditional approaches.
- The work performed is of great interest to regulatory agencies and a paper in a scientific journal will be prepared
Folkehelseinstituttet, Oslo (Hubert Dirven). We will work closely together with selected members of the scientific committee of EBTC to test and verify our ideas
Students are invited to apply for a MSc project on this topic. Minimum period is 12 months. This project is most suitable for a student with a clear interest in regulatory toxicology and development of new methods for assessment and integration of data as performed by European regulatory agencies. Interest in performing literature searches and experience and/or interest with statistical methods is required. Ability to work systematically and to work independently is required.