title: The Use of Published Clinical Study Reports to Support U.S. Food and Drug Administration Approval of Imaging Agents.
abstract: Pharmaceutical companies typically perform prospective, multicenter phase 3 clinical studies to support approval of a new imaging agent by the U.S. Food and Drug Administration (FDA). In uncommon situations, the FDA has approved imaging agents based solely, or in large part, on the clinical study experience described in published reports, including reports of exploratory (i.e., phase 1 or 2) studies performed at a single clinical site. We performed a survey of published reports to assess the potential of the reported information to support FDA approval of a commonly cited investigational imaging agent. Our survey revealed critical data limitations in most publications, all of which reported exploratory clinical studies. Here we summarize the precedent for FDA approval of imaging agents using effectiveness data from publications, FDA guidance, and our experience in reviewing publications. We also present a key-data checklist for investigators to consider in the design, conduct, and reporting of exploratory clinical studies for publication. We encourage editors and peer reviewers to consider requiring these key data when reviewing these reports for publication.
authors.affiliation: Cancer Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland dcrieves@msn.com.
authors.forename: Dwaine
authors.initials: D
authors.lastname: Rieves
authors.affiliation: Cancer Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Paula
authors.initials: P
authors.lastname: Jacobs
mesh_terms: D003952:Diagnostic Imaging; D017277:Drug Approval / Q000379:methods*; D017410:Practice Guidelines as Topic; D011642:Publications; D058028:Research Report; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
keywords: FDA; clinical trial reports; drug approval; imaging agents