Association of Animal Models in the Field of Translational Medicine: Prediction and Validation

Abstract

During clinical development, the success rates for drugs remain low despite large investments. A prominent reason for the poor rate of translation from bench to bedside is generally assumed to be the failure of preclinical animal models to predict clinical efficacy and safety. This failure could be held to problems of internal validity (e.g., poor study design, lack of measures to control biases) and external validity (e.g., poor reproducibility of a research finding, translational failure) in preclinical animal studies. To analyze the significance of animal research impartially, we must warrant that (1) the experiments are conducted and reported according to best scientific practices; (2) the selection of animal models is made with a clear and thorough translational rationale behind it. Once these criteria are met, the true significance of the use of animal models in drug development can be ultimately attested.KeywordsPreclinical animal modelsInternal validityExternal validityExperimental bias