Deane Drug Discovery Institute, Duke University, Durham, NC 27708, USA.
Pharmacogenomics. 2010 Dec;11(12):1657-67. doi: 10.2217/pgs.10.140.
The 2010 US FDA-Drug Industry Association (DIA) Pharmacogenomics Workshop, the fifth in a series of meetings that begun in 2002, brought together multidisciplinary experts from regulatory authorities, medical research, healthcare and drug development. This article summarizes the 'Designing Pharmacogenomic Studies to be Fit for Purpose' track in which considerations regarding the use of retrospective and prospective studies were examined in relation to their ability to influence treatment decisions and labeling for drugs. The aim of the session, using real-world examples (KRAS/panitumumab and HLA-B*5701/abacavir), was to identify good scientific principles that would guide the design of studies to identify subgroups of responders during development programs (including marketed drugs), which could subsequently be used to guide treatment decisions.
2010 年美国食品和药物管理局-药物产业协会（DIA）药物基因组学研讨会是自 2002 年开始的系列会议中的第五次会议，汇集了来自监管机构、医学研究、医疗保健和药物开发等多学科的专家。本文总结了“设计适合目的的药物基因组学研究”这一专题的讨论内容，其中探讨了回顾性和前瞻性研究的使用与它们对药物治疗决策和标签的影响之间的关系。会议的目的是利用真实世界的例子（KRAS/panitumumab 和 HLA-B*5701/abacavir），确定能够指导研究设计的良好科学原则，以在开发计划（包括已上市药物）中识别出应答者亚组，这些亚组随后可用于指导治疗决策。
