title: Perspectives on optimizing trial design and endpoints in peripheral arterial disease: a case for imaging-based surrogates as endpoints of functional efficacy.
abstract: Surrogate endpoints are important for validation of mechanism, early proof of concept, and the rational design of clinical trials for regulatory approval of drugs. The recent failure of several drugs in peripheral arterial disease (PAD) and in atherosclerosis highlights the importance of understanding drug effect and is a clarion call for better endpoints. This review focuses on aspects relating to the current state of surrogate endpoints in PAD and reviews emerging endpoints using imaging approaches that may have the potential of improving study design in PAD.
authors.affiliation: Division of Cardiovascular Medicine, Department of Internal Medicine, The Ohio State University, 473 West 12 Avenue, Columbus, OH 43210, USA. Sanjay.rajagopalan@osumc.edu
authors.forename: Sanjay
authors.initials: S
authors.lastname: Rajagopalan
authors.forename: Georgeta
authors.initials: G
authors.lastname: Mihai
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D058729:Peripheral Arterial Disease / Q000175:diagnosis*; D020127:Recovery of Function; D012107:Research Design