Merck Research Laboratories, North Wales, PA 19454, USA.
Pharmacogenomics. 2010 Dec;11(12):1649-54. doi: 10.2217/pgs.10.139.
Discussion and output from the US FDA and the pharmaceutical industry from the Drug Information Association/FDA 5th Workshop in a series on pharmacogenomics entitled: 'Generating and Weighing Evidence in Drug Development and Regulatory Decision Making'. A major topic area at the 5th FDA/Industry Workshop on Pharmacogenomics, February 2-4, 2010 in Bethesda (MD, USA), was enabling pharmacogenomic clinical trials through collection of future use samples. The importance of the collection of samples with permission for future analyses was affirmed by both industry and the FDA. In addition, current barriers for the collection of such samples were detailed and possible solutions for overcoming barriers at sites, as well as globally within countries, were discussed. The importance of international concordance on collection of these samples was emphasized, and potential areas for industry to harmonize sample collection practices. A standalone workshop on issues related to sampling was determined to be a key step for solving issues related to future use sample collection during drug development.
讨论和输出来自美国 FDA 和制药行业的药物信息协会/FDA 关于药物基因组学的第五次研讨会系列，题为：“在药物开发和监管决策制定中生成和权衡证据”。在 2010 年 2 月 2 日至 4 日在美国马里兰州贝塞斯达举行的第五次 FDA/行业药物基因组学研讨会上，一个主要的主题领域是通过收集未来使用的样本来实现药物基因组学临床试验。行业和 FDA 都肯定了获得未来分析许可的样本收集的重要性。此外，还详细讨论了收集此类样本的当前障碍，以及在站点以及国家内部克服障碍的可能解决方案。强调了在收集这些样本方面国际协调的重要性，以及行业在协调样本收集实践方面的潜在领域。确定单独举办一个关于采样问题的研讨会是解决药物开发过程中未来使用样本收集相关问题的关键步骤。
