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THE MDEPINET MEDICAL COUNTER MEASURES STUDY

MDEPINET 医疗对策研究

基本信息

批准号：
8464322
负责人：
SHARON-LISE Teresa NORMAND
金额：
$ 160.8万
依托单位：
HARVARD MEDICAL SCHOOL
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-15 至 2018-09-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8464322
关键词：
MDEPINET MEDICAL COUNTER MEASURES STUDY

项目摘要

Project Summary. A systematic post-approval assessment of medical device performance depends heavily on the analysis of an expanding universe of observational and globally connected data. Because medical countermeasures (MCM) devices require rapid assessment and approval to ensure an effective public health response in the event of a pandemic or a chemical, biological, radiological, or nuclear (CBRN) threat, exploiting information observed in routine care provides a mechanism to inform regulators and patients about MCM- related device safety and effectiveness. However, predicting vulnerabilities of medical devices to CBRN threats requires an understanding of potential modes of device failure and the likelihoods that specific events would trigger such failures. While premarket and postmarket information can help with these prediction problems, rigorous analytical methods are required to address unique features of the data. We propose to develop and illustrate modern methodology to synthesize information for risk assessment across the total product life cycle. Aim 1 develops and illustrates methodology to bridge premarket and postmarket evidence of MCM- related device safety and effectiveness. We will extend and apply methods to generalize findings from clinical trials to routine care settings by combining study-level and individual-level data using posterior predictive approaches, micro-simulation modeling techniques, and network meta-analyses for up to 9 device areas. Aim 2 focuses on developing a probabilistic risk assessment framework for quantifying the vulnerability of specific devices to CBRN events. We will develop and apply Bayesian methods for up to 5 MCM-related devices to estimate effectiveness accounting for uncertainty in the selection of the confounders and for patient, physician, and device-heterogeneity. Aim 3 implements approaches to postmarket surveillance of MCM-priority medical devices. We will purchase emergency department databases and inpatient databases for 17 geographically diverse states to establish baseline expectations of presenting diagnoses in patients who have had a particular device exposure. This will provide future surveillance efforts with baseline rates to detect occult CBRN events or to estimate the potential public health risk of events. Aim 4 promotes communication with stakeholders and educational outreach of MCM-related medical device surveillance and scientific strategies through publications, scientific presentations, and 2 stakeholder targeted workshops. We will capitalize on relationships and expertise existing in our currently FDA-funded Medical Device Epidemiological Network Methodology Center in order to supplement the scientific and clinical grounding for decision making. We will create a network of clinical investigators and biomedical engineers to study specific devices and their vulnerability to potential CBRN events. Together with FDA investigators, these experts will provide guidance regarding the scope of medical device vulnerabilities, and strategies to minimize the risks to medical devices and the patients who depend on them to such potential threats.

项目摘要。医疗器械性能的系统性批准后评估在很大程度上取决于对不断扩大的观测和全球连接数据进行分析。因为医疗对策（MCM）设备需要快速评估和批准，以确保有效的公共卫生在发生大流行病或化学、生物、放射性或核（CBRN）威胁时做出反应，利用在常规护理中观察到的信息提供了一种机制，向监管机构和患者通报 MCM- 相关设备的安全性和有效性。然而，预测医疗设备对 CBRN 威胁的脆弱性需要了解设备故障的潜在模式以及特定事件发生的可能性引发此类故障。虽然上市前和上市后信息可以帮助解决这些预测问题，需要严格的分析方法来解决数据的独特特征。我们建议开发和说明在整个产品生命周期中综合信息进行风险评估的现代方法。目标 1 开发并说明了连接 MCM 上市前和上市后证据的方法- 相关设备的安全性和有效性。我们将扩展并应用方法来概括临床发现通过使用后验预测结合研究水平和个人水平数据对常规护理环境进行试验方法、微观仿真建模技术以及最多 9 个设备领域的网络元分析。目的 2 重点开发概率风险评估框架，以量化特定风险的脆弱性 CBRN 事件的设备。我们将为最多 5 个 MCM 相关设备开发并应用贝叶斯方法，以估计有效性，考虑到混杂因素选择的不确定性以及患者、医生、和设备异构性。目标 3 实施 MCM 优先医疗的上市后监测方法设备。我们将为17个地区购买急诊科数据库和住院数据库不同的州建立对患有特定疾病的患者进行诊断的基线期望设备暴露。这将为未来的监测工作提供检测隐匿 CBRN 事件的基准率或估计事件的潜在公共卫生风险。目标 4 促进与利益相关者的沟通通过出版物宣传 MCM 相关医疗器械监测和科学策略的教育宣传，科学演示，以及 2 个针对利益相关者的研讨会。我们将利用目前 FDA 资助的医疗器械中现有的关系和专业知识流行病学网络方法学中心，以补充科学和临床基础决策。我们将创建一个临床研究人员和生物医学工程师网络来研究特定的设备及其对潜在 CBRN 事件的脆弱性。这些专家将与 FDA 研究人员一起提供有关医疗设备漏洞范围的指导以及最大限度降低风险的策略医疗设备和依赖它们的患者面临这种潜在的威胁。