The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction
The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction
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DOI：
10.1002/pds.2343
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发表时间：
2012-01-01
影响因子：
2.6
通讯作者：
Weiner, Mark G.
中科院分区：
文献类型：
--
作者：
Platt, Richard;Carnahan, Ryan M.;Weiner, Mark G.
Mini-Sentinel是一项试点计划，旨在开发方法、工具、资源、政策和程序，以促进使用常规收集的电子医疗保健数据对上市医疗产品（包括药物、生物制剂和医疗器械）的安全性进行主动监测。美国食品药品监督管理局（FDA）于2009年启动了该计划，作为其哨兵倡议的一部分，以响应国会在2007年FDA修正案中的授权。两年后，迷你哨兵包括31个学术和私人组织。它已经制定了政策，程序和技术规范，用于开发和操作安全的分布式数据系统，该系统由独立的数据集组成，这些数据集符合通用数据模型，涵盖登记，人口统计学，遭遇，诊断，程序和处方药的门诊配药。分布式数据集目前包括2000年至2011年超过3亿人年、24亿次就诊、3800万次住院治疗和29亿次配药的管理和索赔数据。2005年以后记录的部分实验室结果和生命体征数据也可提供。有一个积极的数据质量评估和表征计划，并有资格获得医疗保健和药房福利。文献的系统性综述评估了管理数据识别感兴趣的健康结局的能力，并开发和测试了程序，以获取、提取和裁定全文病历，以验证编码诊断。Mini-Sentinel还为许多常见情况创建了研究设计和分析方法的分类，并正在开发新的统计和流行病学方法，以解决分析能力方面的某些差距。通过分发由每个数据合作伙伴在本地执行的计算机程序来执行评估。FDA正在积极使用该系统，大多数评估使用可定制、可重复使用的查询（程序）进行。还进行了使用定制方案的前瞻性和回顾性评估。迄今为止，已经分发和执行了数百个独特的程序。目前的活动包括积极监测几种药物和疫苗，扩大人口，加强共同数据模型，包括电子健康记录和登记的其他类型的数据，开发新的方法能力，并评估方法，以确定和验证其他感兴趣的健康结果。版权所有© 2012 John Wiley & Sons，Ltd.
The Mini-Sentinel is a pilot program that is developing methods, tools, resources, policies, and procedures to facilitate the use of routinely collected electronic healthcare data to perform active surveillance of the safety of marketed medical products, including drugs, biologics, and medical devices. The U.S. Food and Drug Administration (FDA) initiated the program in 2009 as part of its Sentinel Initiative, in response to a Congressional mandate in the FDA Amendments Act of 2007. After two years, Mini-Sentinel includes 31 academic and private organizations. It has developed policies, procedures, and technical specifications for developing and operating a secure distributed data system comprised of separate data sets that conform to a common data model covering enrollment, demographics, encounters, diagnoses, procedures, and ambulatory dispensing of prescription drugs. The distributed data sets currently include administrative and claims data from 2000 to 2011 for over 300 million person-years, 2.4 billion encounters, 38 million inpatient hospitalizations, and 2.9 billion dispensings. Selected laboratory results and vital signs data recorded after 2005 are also available. There is an active data quality assessment and characterization program, and eligibility for medical care and pharmacy benefits is known. Systematic reviews of the literature have assessed the ability of administrative data to identify health outcomes of interest, and procedures have been developed and tested to obtain, abstract, and adjudicate full-text medical records to validate coded diagnoses. Mini-Sentinel has also created a taxonomy of study designs and analytical approaches for many commonly occurring situations, and it is developing new statistical and epidemiologic methods to address certain gaps in analytic capabilities. Assessments are performed by distributing computer programs that are executed locally by each data partner. The system is in active use by FDA, with the majority of assessments performed using customizable, reusable queries (programs). Prospective and retrospective assessments that use customized protocols are conducted as well. To date, several hundred unique programs have been distributed and executed. Current activities include active surveillance of several drugs and vaccines, expansion of the population, enhancement of the common data model to include additional types of data from electronic health records and registries, development of new methodologic capabilities, and assessment of methods to identify and validate additional health outcomes of interest. Copyright c 2012 John Wiley & Sons, Ltd.