Methodological Rigour in Preclinical Research: Implications for its Scientific Validity and Biomedical Progress

Abstract

Preclinical research using animals often precedes and informs clinical trials; however, most attempts to translate findings from “bench-to-bedside” fail. There is growing concern that an important cause of failed translations is that much of preclinical research is not reproducible, with poor experimental methodology believed to be a major contributor. Four studies were conducted: (1) an assessment of reported study designs of preclinical experiments published in leading cardiovascular journals; (2) an examination of sex bias in preclinical cardiovascular research; (3) a comparison of experimental practices between male and female preclinical cardiovascular researchers; and (4) an analysis of the influence of journal initiatives on preclinical research quality. These studies suggest that (1) methodological shortcomings are prevalent and persistent in preclinical cardiovascular research; (2) women’s involvement in preclinical cardiovascular research is positively associated with considering sex as a biological variable; and (3) journals can exert considerable influence on the quality of published data.