Use of Imaging Endpoints in Clinical Trials

Linda D. Gillam, Jonathon Leipsic, Neil J. Weissman

Research output: Contribution to journalReview article

5 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)296-303
Number of pages8
JournalJACC: Cardiovascular Imaging
Volume10
Issue number3
DOIs
StatePublished - Mar 1 2017
Externally publishedYes

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Clinical Trials
United States Food and Drug Administration
Technology
Equipment and Supplies
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Gillam, Linda D. ; Leipsic, Jonathon ; Weissman, Neil J. / Use of Imaging Endpoints in Clinical Trials. In: JACC: Cardiovascular Imaging. 2017 ; Vol. 10, No. 3. pp. 296-303.
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Use of Imaging Endpoints in Clinical Trials. / Gillam, Linda D.; Leipsic, Jonathon; Weissman, Neil J.

In: JACC: Cardiovascular Imaging, Vol. 10, No. 3, 01.03.2017, p. 296-303.

Research output: Contribution to journalReview article

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