The ability of animal studies to detect serious post marketing adverse events is limited

The value of animalstudies to the assessment of drug safety is unclear because many such studies are biased and have methodological shortcomings. We studied whether post-marketing seriousadverse reactions to small molecule drugs could have been detected on the basis of animalstudy data included in drug registration files. Of 93 seriousadverse reactions related to 43 small molecule drugs, only 19% were identified in animalstudies as a true positive outcome, which suggests that data from animalstudies are of limited value to pharmacovigilance activities. Our study shows that drug registration files can be used to study the predictive value of animalstudies and that the value of animalstudies in all stages of the drug development should be investigated in a collaborative endeavour between regulatory authorities, industry, and academia.