Brain Imaging Center, McLean Hospital, 115 Mill St. Belmont, MA 02478, USA.
Drug Discov Today. 2011 Jul;16(13-14):583-93. doi: 10.1016/j.drudis.2011.05.006. Epub 2011 May 24.
There is increasing interest in the application of quantitative magnetic resonance imaging (MRI) methods to drug development, but as yet little standardization or best practice guidelines for its use in this context. Pharmaceutical trials are subject to regulatory constraints and sponsor company processes, including site qualification and expectations around study oversight, blinding, quality assurance and quality control (QA/QC), analysis and reporting of results. In this article, we review the processes on the sponsor side and also the procedures involved in data acquisition at the imaging site. We then propose summary recommendations to help guide appropriate imaging site qualification, as part of a framework of 'good imaging practice' for functional (f)MRI studies applied to drug development.
人们对将定量磁共振成像（MRI）方法应用于药物开发越来越感兴趣，但在这种情况下，其使用几乎没有标准化或最佳实践指南。药物试验受到监管限制和赞助商公司流程的约束，包括对研究监督、盲法、质量保证和质量控制（QA/QC）、分析和结果报告的期望。在本文中，我们回顾了赞助商方面的流程以及成像现场数据采集所涉及的程序。然后，我们提出了总结性建议，以帮助指导适当的成像现场资格认证，作为适用于药物开发的功能（f）MRI 研究的“良好成像实践”框架的一部分。
