Mining the IMI eTOX database: a systematic analysis of preclinical toxicity data
While toxicity observed during preclinical stages of drug development continues to be a leading cause of drug attrition, a systematic evaluation of the frequency of a particular treatment related toxicity finding across studies, the concordance between histopathological and clinical chemistry findings, the impact of study duration, species-specificity of a particular toxicity finding, and finally incidences in control animals, has been hampered by the lack of access to sufficiently large and representative data sets of high-quality in vivo preclinical safety data generated by pharmaceutical companies during drug development.
The Innovative Medicines Initiative (IMI) JU eTOX project was initiated to develop innovative strategies and novel software tools to better predict the safety and the side-effects of new candidate medicines. Core to this project, the eTOXsys database was established by extracting in vivo preclinical safety data from systemic toxicity reports of the participating pharmaceutical companies. The eTOXsys database, currently the largest and most detailed preclinical database, provides a unique opportunity to systematically analyse preclinical toxicity data across multiple companies and extract information which may help improve testing and decision making in drug development.
The overall objective of this project is to mine the eTOXsys database in order to obtain reliable data on the frequency of different types of toxicity findings and consistency across study duration and species.