Purpose: Pre-clinical data can provide a rationale for subsequent clinical trials and they are the first step in drug development; however, the therapeutic effect observed during animal studies does not necessarily translate to similar results in humans.
Methods: Taking the example of pulmonary hypertension, the present study explores whether the methodological aspects of preclinical experiments can determine the final result.
Results: The present paper describes a systematic analysis of 409 studies conducted on a variety of animal models to identify potential drug candidates for PH treatment; it explores the influence of various aspects of study design on the final outcome, e.g. type of animal model of PH, dosage schedules of tested agents, type of anesthesia, measurement of exercise intolerance or animal survival.
Conclusions: The animal models of PH used for pre-clinical studies are diverse and there are several methodological items within the established protocols that can determine the obtained result. Graphical abstract.
Keywords: Animal model; Bias; Experimental; New agents; Pulmonary hypertension.