Innovation in Medical Evidence Development and Surveillance(IMEDS)serves to advance the science and tools necessary to support post-market evidence generation on regulated products.

机会标题：IMEDS-方法研究议程 提供机构：美国食品和药物管理局 中国食品药品监督管理局编号：93.103 中国食品药品监督管理局描述：食品和药物管理局研究 商机编号：RFA-FD-15-010 少年派：苏珊·格鲁伯 项目名称：IMEDS-方法研究议程 摘要： IMEDS-METHOD是里根-乌德尔基金会(RUF)内的一个项目，支持FDA的 通过发起和促进方法研究来服务于公共卫生需求的科学使命 在大型数据库中进行安全评估。IMEDS-METHANDS旨在改进进行后评估的工具 推广使用自动化医疗数据的安全监控，并促进其采用。在会议中 这项任务，IMEDS-方法，也增加了使用自动化健康的一般知识体系 关于受管制产品的更广泛的上市后证据生成数据。1 IMEDS方法计划的首要目标是减少FDA正在进行的 对上市医疗产品的评价。IMEDS-方法2015年研究议程上的项目包括 旨在提高我们使用电子医疗数据为监管决策提供信息的能力- 制作。 IMEDS计划为五个核心领域的项目提供资金：(1)解决观测估计的偏差问题 研究；(2)更好地理解数据的用途和局限性；(3)应用从 早期IMEDS项目到FDA的监测活动；(4)将监测问题扩大到 持续的风险/收益评估；以及(5)继续支持业界的合格调查人员， 通过提供对未识别的电子医疗数据的访问，以及 通过IMEDS研究实验室提供计算资源。对IMEDS研究的改进 实验室包括为研究人员开发新的工具和额外的数据源 社区。 1《医学证据开发和监督创新宪章》。Http://www.reaganudall.org/our-work/safety- And%20better-evidence/imeds-program/imeds-charter/于2013年9月30日访问。初稿完成日期：2013年4月 拟议修订草案：2013年8月；第3.1节

Opportunity Title: IMEDS-Methods Research Agenda Offering Agency: Food and Drug Administration CFDA Number: 93.103 CFDA Description: Food and Drug Administration_Research Opportunity Number: RFA-FD-15-010 PI Name: Susan Gruber Project Title: IMEDS-Methods Research Agenda Abstract: IMEDS-Methods is a program within the Reagan-Udall Foundation (RUF) that supports the FDA’s scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. IMEDS-Methods aims to improve the tools for conducting post- marketing safety surveillance using automated healthcare data and to foster their adoption. In meeting this mission, IMEDS-Methods also adds to the general body of knowledge for using automated health data for broader post-market evidence generation on regulated products.1 The overarching goal of the IMEDS-Methods Program is to reduce uncertainty in the FDA’s ongoing evaluation of marketed medical products. Projects on the IMEDS-Methods 2015 Research Agenda are geared towards improving our ability to use electronic healthcare data to inform regulatory decision- making. IMEDS plans to fund projects in five core areas: (1) addressing bias in estimates from observational studies; (2) better understanding uses and limitations of the data; (3) applying lessons learned from earlier IMEDS projects to FDA surveillance activities; (4) expanding the surveillance question to continuous Risk/Benefit assessment; and (5) continuing to support qualified investigators in industry, government, and academic settings by providing access to de-identified electronic healthcare data and computing resources through the IMEDS Research Laboratory. Enhancements to the IMEDS Research Lab include developing novel tools and additional data sources to investigators in the research community. 1 Innovation in Medical Evidence Development and Surveillance (IMEDS) Charter. http://www.reaganudall.org/our-work/safety- and%20better-evidence/imeds-program/imeds-charter/ accessed September 30, 2013. First Draft Completed: April 2013 Proposed Revised Draft: August 2013; Section 3.1