RT Journal Article SR Electronic T1 The Use of Published Clinical Study Reports to Support U.S. Food and Drug Administration Approval of Imaging Agents JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP 2022 OP 2026 DO 10.2967/jnumed.116.178814 VO 57 IS 12 A1 Rieves, Dwaine A1 Jacobs, Paula YR 2016 UL http://jnm.snmjournals.org/content/57/12/2022.abstract AB 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.