Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Health Aff (Millwood). 2012 Oct;31(10):2188-92. doi: 10.1377/hlthaff.2012.0958.
As norms of comparative effectiveness research are sought within the biomedical and health care communities, and the science of conducting and interpreting this research develops, the Food and Drug Administration (FDA) must balance diverse interests. The agency's overarching interest is the development of high-quality comparative effectiveness information that contributes to improved patient care. To further this interest, the FDA can provide expertise in trial design and postmarketing surveillance. The FDA can also ensure that manufacturers of medical products use comparative effectiveness information in product promotion in a manner consistent with regulatory requirements. In this article we observe that these requirements would preclude the manufacturer's use in a promotional context of comparative effectiveness findings derived from an observational study. The FDA recognizes, however, that there are ongoing efforts to address the methodological problems inherent in observational approaches and to foster consensus on enhanced methods. The FDA must work to navigate challenges that relate to both the science of comparative effectiveness research and the agency's statutory responsibilities to the public health.
随着生物医学和医疗保健界寻求比较效果研究的规范，以及开展和解释这项研究的科学不断发展，食品和药物管理局 (FDA) 必须平衡各种利益。该机构的首要利益是开发有助于改善患者护理的高质量比较效果信息。为了进一步实现这一利益，FDA 可以在试验设计和上市后监测方面提供专业知识。FDA 还可以确保医疗产品制造商以符合监管要求的方式在产品推广中使用比较效果信息。在本文中，我们观察到这些要求将排除制造商在宣传中使用来自观察性研究的比较效果发现。然而，FDA 认识到，目前正在努力解决观察性方法所固有的方法学问题，并就加强方法达成共识。FDA 必须努力应对与比较效果研究的科学性以及机构对公共卫生的法定责任相关的挑战。
