Rieves Dwaine, Jacobs Paula
Cancer Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
Cancer Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
J Nucl Med. 2016 Dec;57(12):2022-2026. doi: 10.2967/jnumed.116.178814. Epub 2016 Jul 21.
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.
制药公司通常会开展前瞻性、多中心3期临床研究，以支持美国食品药品监督管理局（FDA）批准一种新的成像剂。在罕见情况下，FDA仅基于或很大程度上基于已发表报告中描述的临床研究经验批准成像剂，这些报告包括在单个临床地点进行的探索性（即1期或2期）研究报告。我们对已发表报告进行了一项调查，以评估所报告信息支持FDA批准一种常用的研究性成像剂的可能性。我们的调查揭示了大多数出版物中存在关键数据限制，所有这些出版物均报告了探索性临床研究。在此，我们根据出版物中的有效性数据、FDA指南以及我们在审阅出版物方面的经验，总结FDA批准成像剂的先例。我们还提供了一份关键数据清单，供研究人员在设计、开展和报告用于发表的探索性临床研究时考虑。我们鼓励编辑和同行评审人员在审阅这些报告以供发表时考虑要求提供这些关键数据。
