title: Rethinking Phase II Clinical Trial Design in Heart Failure.
abstract: The incidence and economic burden of heart failure continue to rise worldwide, despite implementation of a number of effective heart failure therapies. Although there have been a number phase I-II studies of potential novel heart failure therapies over the past decade, none of these new compounds have been successful in phase III clinical trials. While there are likely a number of reasons for this failure, one of the problems that has become increasingly apparent is the inability of phase II trials to correctly identify novel therapies that will be successful in phase III clinical trials. In the following review, we will discuss the some of the problems inherent with current phase II heart failure clinical trials, as well as discuss possible ways to rethink phase II development of new therapies for heart failure.
authors.affiliation: Center for Cardiovascular Research, Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri 63110.
authors.forename: Kory J
authors.initials: KJ
authors.lastname: Lavine
authors.affiliation: Center for Cardiovascular Research, Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri 63110.
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Mann
keywords: Heart failure; adaptive study design; clinical translation; clinical trial design; phase II