TY  - BOOK
AU  - Weissman, Neil J
TI  - Use of Imaging Endpoints in Clinical Trials. [Review]
SN  - 1876-7591
PY  - 2017///
KW  - *Cardiac Imaging Techniques
KW  - *Cardiovascular Diseases/dg [Diagnostic Imaging]
KW  - *Clinical Trials as Topic/mt [Methods]
KW  - *Endpoint Determination
KW  - *Research Design
KW  - Cardiac Imaging Techniques/st [Standards]
KW  - Cardiovascular Diseases/th [Therapy]
KW  - Clinical Trials as Topic/st [Standards]
KW  - Endpoint Determination/st [Standards]
KW  - Humans
KW  - Observer Variation
KW  - Predictive Value of Tests
KW  - Reproducibility of Results
KW  - Research Design/st [Standards]
KW  - United States
KW  - United States Food and Drug Administration
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
KW  - Review
N2  - 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; Copyright � 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved
UR  - https://dx.doi.org/10.1016/j.jcmg.2016.12.003
ER  -