Does a preclinical randomized controlled trial, pRCT, resolve the gap between animal studies and human trials?

Abstract

In drug development, preclinical studies using laboratory animals are crucial to test efficacy and safety of drug candidates. However, there have been discrepancies between animal studies and clinical trials in human patients. Preclinical randomized controlled trials, as reported by Lei et al. in this issue of Kidney International, may reduce the gap between experimental studies and randomized controlled trials in human patients, although there remain issues to be addressed.