Abstract
Large amounts of data associated with safety issues are generated along the entire lifetime of drugs, from its infancy as preclinical leads, through its adolescence as clinical candidates, all the way up to its adulthood as marketed drugs exposed to the human population. Across the different stages in the life of a drug, some of the data collected initially may be confirmed and consolidated with data at an advanced stage, whereas other data may not be translated, and in some cases may even contradict, those safety signals that are ultimately observed in the human population. Collecting and properly integrating such an heterogenous pool of data is already a challenge in itself. But even if one manages to put all data together, the analysis is not straightforward, and it may require the assistance of purposely designed visual analytics tools.
To this aim, we introduce the newly designed Translational Safety Charts that collect, in a single image, data from safety pharmacology, preclinical toxicology, clinical safety and postmarketing surveillance. They are implemented in CLARITY.PV, a new pharmacovigilance web-accessible platform that currently contains Translational Safety Charts for 8,060 drugs. A thoroughly validated methodology has been implemented to detect consolidated drug safety signals and link them to pharmacology, preclinical and clinical biomarkers. The analysis of safety signals can be extended beyond individual drugs to drug classes and stratified by age, weight, gender and geographical location.
