Reassessing the Role of Surrogate End Points in Drug Development for Heart Failure.

ABSTRACT: With few notable exceptions, drug development for heart failure (HF) has become progressively more challenging, and there remain no definitively proven therapies for patients with acute HF or HF with preserved ejection fraction. Inspection of temporal trends suggests an increasing rate of disagreement between early-phase and phase III trial end points. Preliminary results from phase II HF trials are frequently promising, but increasingly followed by disappointing phase III results. Given this potential disconnect, it is reasonable to carefully re-evaluate the purpose, design, and execution of phase II HF trials, with particular attention directed toward the surrogate end points commonly used by these studies. In this review, we offer a critical reappraisal of the role of phase II HF trials

SUBMITTER: Greene SJ 

PROVIDER: S-EPMC6205720 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature