Department of Medical and Analytical Affairs, Medco Health Solutions, Inc., Franklin Lakes, New Jersey, USA.
Pharmacoeconomics. 2010;28(10):905-13. doi: 10.2165/11535830-000000000-00000.
Comparative effectiveness research (CER) is generating intense attention as interest grows in finding new and better drug technology assessment processes. The federal government is supporting the expansion of CER through funding made available in the American Recovery and Reinvestment Act of 2009 (ARRA) and by establishing the Patient-Centered Outcomes Research Institute through the Patient Protection and Affordable Care Act of 2010. At the same time, personalized medicine is generating debate about its place in clinical medicine, and so, naturally, how CER can or cannot play a role in personalized medicine is part of these debates. At the heart of the debate around the role of CER in personalized medicine is the nature of personalized medicine and how it fits within contemporary clinical research concepts. We maintain in this article that CER can serve to catalyze personalized medicine, but we recognize that, for this to happen, researchers will need to embrace new data sources and new analytic approaches. We also recognize that drug technology assessment processes will have to undergo necessary adaptations to accommodate CER as configured for personalized medicine, and that clinicians will need to be educated appropriately and provided access to decision-support systems through health information technology to use the information coming from this research. To illustrate our argument, we describe two ongoing CER studies funded and managed in the private sector evaluating personalized medicine interventions that have important clinical and financial implications. One of the studies investigates the clinical and financial effects of pharmacogenomic testing for warfarin as prescribed in conditions of typical practice settings. The other study is also set in community practice settings and compares cardiovascular outcomes of patients receiving clopidogrel who are extensive metabolizer phenotypes for the cytochrome P450 2C19 hepatic isoenzyme with all patients receiving prasugrel.
比较疗效研究（CER）越来越受到关注，因为人们对寻找新的和更好的药物技术评估过程产生了兴趣。联邦政府通过 2009 年《美国复苏与再投资法案》（ARRA）提供的资金以及通过 2010 年《患者保护与平价医疗法案》设立患者为中心的成果研究学会来支持 CER 的扩展。与此同时，个性化医学正在引发关于其在临床医学中地位的争论，因此，CER 如何以及是否可以在个性化医学中发挥作用自然是这些争论的一部分。在 CER 在个性化医学中的作用的争论的核心是个性化医学的性质以及它如何适应当代临床研究概念。我们在本文中认为，CER 可以促进个性化医学，但我们认识到，要做到这一点，研究人员将需要采用新的数据源和新的分析方法。我们还认识到，药物技术评估流程将必须进行必要的调整，以适应针对个性化医学配置的 CER，并且临床医生需要通过健康信息技术获得适当的教育并获得决策支持系统，以使用来自这项研究的信息。为了说明我们的观点，我们描述了两个正在进行的由私营部门资助和管理的 CER 研究，这些研究评估了具有重要临床和财务意义的个性化医学干预措施。其中一项研究调查了华法林个体化用药检测在典型实践环境下的临床和财务影响。另一项研究也设在社区实践环境中，比较了接受氯吡格雷治疗的患者的心血管结局，这些患者是细胞色素 P450 2C19 肝同工酶的广泛代谢表型，而所有接受普拉格雷治疗的患者。
