Incorporating biomarkers into clinical trials in cardiovascular medicine

Developing novel therapies and establishing clinical benefits over conventional therapies has become a highly competitive and a costly endeavor. In this regard, biomarkers have become increasingly important in accurately assessing both efficacy and safety of these novel therapies. While the use of biomarkers has proved vital in cardiovascular research and disease management, current established biomarkers are inadequate in capturing and accounting for the entire cardiovascular disease process and responses to therapeutic interventions. Substantial effort has been made in exploring and clinically evaluating novel biomarkers. The present review aims to shed light on some of the novel cardiovascular biomarkers being investigated, including high sensitivity C-reactive protein, proprotein convertase subtilisin/kexin type 9, P-selectin, secretory phospholipase A 2 , lipoprotein-associated phospholipase A 2 , and growth differentiation factor 15, and illustrate their relevance to clinical research.