Pharmacogenetics in Europe: Barriers and Opportunities
Pharmacogenetics in Europe: Barriers and Opportunities
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DOI：
10.1159/000189625
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发表时间：
2009-01-01
影响因子：
1.7
通讯作者：
Ibarreta, D.
中科院分区：
文献类型：
--
作者：
Gurwitz, D.;Zika, E.;Ibarreta, D.
本文综述了欧洲药物遗传学/药物基因组学（PGx）领域的现状。围绕PGx临床应用的高期望在很大程度上仍未实现，因为只有有限数量的此类应用实际进入市场和临床实践。因此，基于pgx的诊断对医疗保健及其社会经济影响的潜在影响仍不清楚。为了阐明这些不确定性，欧洲委员会联合研究中心（JRC）的前瞻性技术研究所（IPTS）对欧洲的“最新技术”进行了审查，并进一步分析了药物遗传学诊断在预防药物毒性反应和提高药物疗效方面的使用。本文介绍了JRC-IPTS研究的亮点，并通过比较美国的一些经验，讨论了提高欧洲PGx研究翻译的可能性。我们还通过具体的案例研究说明了欧洲临床使用PGx的相关障碍。所确定的大多数障碍都超出了欧洲范围。这反映了全球性的问题，即缺乏证明临床有效性或效用的数据和有利的成本效益研究，以支持PGx诊断测试在临床环境中的临床应用。另一个关键障碍是缺乏鼓励私营部门投资开发和许可PGx诊断测试，以提高专利过期药物的安全性和有效性。因此，政策可以影响PGx临床应用的一个关键方面似乎是通过维持大规模的产学研合作来开发和证明PGx诊断的实用性。版权所有(C) 2009 S. Karger AG，巴塞尔
This paper reviews the current situation in the field of pharmacogenetics/pharmacogenomics (PGx) in Europe. High expectations surrounding the clinical application of PGx remain largely unmet, as only a limited number of such applications have actually reached the market and clinical practice. Thus, the potential impact of PGx-based diagnostics on healthcare and its socio-economic implications are still unclear. With the aim of shedding some light on these uncertainties, the Institute for Prospective Technological Studies (IPTS) of the European Commission's Joint Research Centre (JRC) has conducted a review of the 'state of the art' and a further analysis on the use of pharmacogenetics diagnostics for preventing toxic drug reactions and improving drug efficacy in Europe. The paper presents highlights from the JRC-IPTS studies and discusses possibilities for improving translation of PGx research in Europe by comparing some experiences in the USA. We also illustrate the related barriers for the clinical uptake of PGx in Europe with specific case-studies. Most of the barriers identified extend beyond the European context. This reflects the global problems of scarcity of data demonstrating proven clinical validity or utility and favorable cost-effectiveness studies to support the clinical application of PGx diagnostic tests in the clinical setting. Another key barrier is the lack of incentives for the private sector to invest in the development and licensing of PGx diagnostic tests for improving the safety and efficacy of out-of-patent drugs. it therefore seems that one key aspect where policy can affect the clinical uptake of PGx is via sustaining large-scale industry-academia collaborations for developing and proving the utility of PGx diagnostics. Copyright (C) 2009 S. Karger AG, Basel