Clinical trials in cardiology: pinnacle or inflection point?

Abstract

Controlled clinical trials conduct the research that completes the causal argument between a treatment and a disease's control. Yet, this pinnacle of clinical research is itself afflicted. Chronic problems with recruitment failure vitiate the potency of our research efforts. In addition, the collision of end-point multiplicity (the drive to measure multiple end points) with the requirement of statistical parsimony (ie, the need to reduce the number of interpretable end points to control the overall type I error) induces a core inefficiency in clinical trial productivity by reducing the number of endpoints findings that are generalizable to the population at large. Unless clinical trialists engage these problems with vigor and imagination, our pinnacle may be nothing more than an inflection point leading to decline.