title: Use of Imaging Endpoints in Clinical Trials.
abstract: Cardiovascular imaging is an integral component of many clinical trials beyond those for which the primary goal is to evaluate or validate imaging technologies. The scope of such trials is broad, ranging from those in which a medical, surgical, or interventional cardiovascular device or drug is being evaluated to those in which there is concern about cardiovascular adverse events complicating treatment for noncardiac conditions. This paper discusses study design as it pertains to the incorporation of imaging elements, the important role played by imaging core laboratories, the rationale for and approaches to involvement of imagers in clinical trials, and guidance by the U.S. Food and Drug Administration on imaging endpoints in clinical trials.
authors.affiliation: Morristown Medical Center, Morristown, New Jersey. Electronic address: linda.gillam@atlantichealth.org.
authors.forename: Linda D
authors.initials: LD
authors.lastname: Gillam
authors.affiliation: Centre for Heart Valve Innovation UBC, Vancouver, British Columbia, Canada.
authors.forename: Jonathon
authors.initials: J
authors.lastname: Leipsic
authors.affiliation: MedStar Health Research Institute and Georgetown University, Washington, DC.
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
mesh_terms: D057791:Cardiac Imaging Techniques / Q000592:standards; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging* / Q000628:therapy; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D023381:Endpoint Determination / Q000592:standards; D006801:Humans; D015588:Observer Variation; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
keywords: cardiac computed tomography; cardiac magnetic resonance imaging; clinical trials; core laboratory; echocardiography; imaging; nuclear cardiology