Translational Medicine and Bioengineering

Translational Pharmacology

Pre-clinical studies using animal models play a very important role in the evaluation of efficacy and safety of new medical diagnostic devices before their use in human clinical studies. It provides an overview of the emerging role, results of pre-clinical studies and development, and evaluation of animal models for percutaneous cardiovascular intervention technologies for patients with symptomatic cardiovascular disease such as cardiac arrest or coronary heart disease. One prominent explanation is flawed preclinical research, in which the use and outcome of animal models is pivotal to bridge the translational gap to the clinic. Therefore, the selection of a validated and predictive animal model is essential to address the clinical question. In this review, the current challenges and limitations of animal models are discussed, with a focus on the fit-for-purpose validation.

Animal models are essential for translation of drug findings from bench to bedside. Hence, critical evaluation of the face and predictive validity of these models is important. Reversely, clinical bedside findings that were not predicted by animal testing should be back translated and used to refine the animal models. The translation of findings from bench to clinically relevant therapies is very complex. In fact, despite a full preclinical and clinical trial package, the large majority of drugs with initial phases based on translational-laboratory based discoveries actually fail to complete the development process. A lack of efficacy, side-effects, inappropriate doses, and pharmacokinetics are just a few of the various reasons for this failure.