Where Statisticians can Contribute to Address Future Challenges for Drug Regulatory Agencies: A View from the European Medicines Agency (EMEA)
Where Statisticians can Contribute to Address Future Challenges for Drug Regulatory Agencies: A View from the European Medicines Agency (EMEA)
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DOI：
10.1198/sbr.2009.0054
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发表时间：
2010-08-01
影响因子：
1.8
通讯作者：
Vamvakas, Spiros
中科院分区：
文献类型：
--
作者：
Eichler, Hans-Georg;Hemmings, Robert J.;Vamvakas, Spiros
药品监管机构需要高水平的生物统计专业知识和经验。在本文中，我们简要讨论了不断发展的环境将如何在监管科学中带来需要统计输入的新领域，包括审查和越来越多地进行荟萃分析的新需求;主动药物警戒;监管结果评估;以及获益-风险评估和沟通的新方法。对于许多监管机构，包括欧洲监管网络内的监管机构，这可能需要扩大其生物统计学技能基础，并需要医学生物统计学家，药物流行病学家和其他定量科学家之间更密切的合作。
Drug regulatory agencies require a high level of biostatistical expertise and experience. In this article we briefly discuss how an evolving environment will bring about new areas in regulatory sciences where statistical input will be required, including the emerging need to review and increasingly conduct meta-analyses; proactive pharmacovigilance; regulatory outcomes assessment; and novel methodologies of benefit-risk assessment and communication. For a number of regulatory agencies, including those within the European Regulatory Network, this may create a need to broaden their biostatistical skill base, and for closer collaboration between medical biostatisticians, pharmaco-epidemiologists, and other quantitative scientists.