Gerard A. Rongen
Radboud university medical center, The Netherlands
Title: Cardiovascular pharmacotherapy: Innovation stuck in translation
Biography
Biography: Gerard A. Rongen
Abstract
Systematic reviews of animal studies have revealed serious limitations in internal and external validity strongly affecting the reliability of this research. In addition inter-species differences are likely to further limit the predictive value of animal research for the efficacy and tolerability of new drugs in humans. Important changes in the research process are needed to allow efficient translation of preclinical discoveries to the clinic, including improvements in the laboratory and publication practices involving animal research and early incorporation of human proof-of-concept studies to optimize the interpretation of animal data for its predictive value for humans and the design of clinical trials. Illustrated by recent clinical trials in the area of (cardiac) ischemia-reperfusion injury performed by this author and his colleagues, the impact of translational problems between animals and humans will be discussed on clinical development of therapeutics.