Distributed, Collaborative Intelligent Agents for Proactive Post-Marketing Drug S

用于主动上市后药物的分布式协作智能代理

• 批准号: 7532069
• 负责人: HAO YING
• 金额: $ 22.88万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7532069
• 关键词: Address; Adverse reactions; Antihypertensive Agents; Architecture; Artificial Intelligence; Benefits and Risks; Bioterrorism; Boxing; Cessation of life; Cisapride; Class; Clinical; Clinical Medicine; Cognitive; Computer information processing; Computer software; Computerized Medical Record; Condition; Country; Data Security; Decision Making; Detection; Development; Dose; Drug usage; Early Diagnosis; Event; Family Practice; Formularies; Frequencies; Health Care Costs; Health care facility; Healthcare; Healthcare Systems; Insurance Carriers; Internal Medicine; Internet; Label; Lead; Literature; Marketing; Medical; Medical Surveillance; Medical center; Methodology; Modeling; Monitor; Morbidity - disease rate; Names; Nature; Operating System; Patients; Performance; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Phase; Physicians; Pilot Projects; Play; Policies; Population Surveillance; Publishing; Rate; Reaction; Reporting; Research; Risk; Role; Safety; Signal Transduction; System; Technology; Testing; Uncertainty; United States Food and Drug Administration; Universities; Withdrawal; base; cohort; computerized; cost; design; drug market; improved; innovation; interest; member; mortality; multidisciplinary; novel; patient privacy; post-market; prototype; software development

DESCRIPTION (provided by applicant): Healthcare systems and insurers nationwide regularly make decisions regarding which drugs to include or exclude from their formularies based on evidence concerning benefits, risks, and costs of the medications. A major barrier to effective drug selection is the lack of sufficient published information on the safety of drugs, particularly new drugs. A computerized system operating at healthcare facilities that could provide continuous, active surveillance and timely identification of potential safety issues following the introduction of a new drug to a formulary is highly desirable. Such a system could lead to safer drug use policy, more cost-effective formulary decisions, better healthcare, and earlier detection of adverse drug reactions (ADRs). The implications of such technology for improving a national drug surveillance system will be apparent because ADRs can complicate the patient's medical condition, increase morbidity, and result in death (about 7,000 deaths per year in the U.S. were attributed to ADRs). At present, evidence on safety issues that would inform these decisions is generated primarily by the FDA's post-marketing surveillance system MedWatch(tm). MedWatch(tm) is a passive system that depends on voluntary, spontaneous reports. Because the system is limited by low reporting rates and the slow accumulation of sufficient events to enable a critical analysis, delays occur in the identification and withdrawal of problematic drugs from the market or labeling them with black box warnings. These delays have resulted in unnecessary mortality, morbidity, and costs of healthcare. We propose to develop an innovative team-based agent system, named ADRMonitor, for actively monitoring and detecting signal pairs implicating anticipated or potential ADRs at a healthcare facility. Each ADRMonitor user (e.g., physicians and drug safety officers) will have his/her own software agent that is accessible via the Internet and plays two roles -- assisting the user in his/her decision-making, and collaborating with agents of other team members. A key feature of the proposed approach is that the agents will continuously and autonomously collaborate with one another. They anticipate information needs of their teammates and share information proactively so that the users can be alerted timely about signal pairs. To demonstrate the feasibility, we plan to develop a prototype of ADRMonitor in this two-year pilot project, which will be undertaken collaboratively by our multidisciplinary team. Our preliminary design and analysis show the proposed methodology to be promising. The proposed effort represents a critical first step toward a subsequent development of a more comprehensive ADRMonitor in later phases of this research endeavor that would use the signal pairs to detect ADRs and expand the resultant system to cover healthcare in a region or across the country. The proposed methodology is general in nature and can be adapted for other important applications such as bioterrorism surveillance. PUBLIC HEALTH RELEVANCE: A computerized system operating at healthcare facilities that could provide continuous, active surveillance and timely identification of potential safety issues following the introduction of a new drug to a formulary is highly desirable. Such a system could lead to safer drug use policy, more cost-effective formulary decisions, better healthcare, and earlier detection of adverse drug reactions (ADRs). The implications of such technology for improving a national drug surveillance system will be apparent because ADRs can complicate the patient's medical condition, increase morbidity, and result in death (about 7,000 deaths per year in the U.S. were attributed to ADRs).

描述（由申请人提供）：全国范围内的医疗保健系统和保险公司定期根据有关药物益处、风险和成本的证据，决定将哪些药物纳入或排除在处方集之外。有效药物选择的一个主要障碍是缺乏足够的药物安全性公开信息，尤其是新药。在医疗机构运行的计算机化系统，可以提供连续的，积极的监测和及时识别潜在的安全问题后，新的药物引入处方集是非常可取的。这样的系统可以导致更安全的药物使用政策，更具成本效益的处方决策，更好的医疗保健，以及更早地发现药物不良反应（ADR）。这种技术对改善国家药物监测系统的影响将是显而易见的，因为ADR会使患者的医疗状况复杂化，增加发病率并导致死亡（美国每年约有7，000例死亡归因于ADR）。目前，FDA的上市后监测系统MedWatch（tm）主要提供有关安全性问题的证据，为这些决策提供信息。MedWatch（tm）是一个被动系统，依赖于自愿、自发的报告。由于该系统受到报告率低以及足够事件积累缓慢以进行批判性分析的限制，因此在识别和从市场上撤回问题药物或给它们贴上黑盒警告标签时会出现延迟。这些延误导致了不必要的死亡率、发病率和医疗费用。 我们建议开发一个创新的团队为基础的代理系统，名为ADRMonitor，积极监测和检测信号对暗示预期或潜在的药物不良反应在医疗机构。每个ADRMonitor用户（例如，医生和药物安全官员）将拥有自己的软件代理人，可通过互联网访问，并发挥两种作用-协助用户作出决策，并与其他团队成员的代理人合作。所提出的方法的一个关键特征是，代理人将不断地和自主地相互协作。他们预测队友的信息需求并主动共享信息，以便用户可以及时获得有关信号对的警报。 为了证明其可行性，我们计划在这个为期两年的试点项目中开发一个ADRMonitor原型，该项目将由我们的多学科团队合作进行。我们的初步设计和分析表明，所提出的方法是有前途的。拟议的努力代表了在本奋进后期开发更全面的ADRMonitor的关键第一步，该研究将使用信号对来检测ADR，并将由此产生的系统扩展到覆盖一个地区或全国的医疗保健。拟议的方法是一般性的，可以适用于其他重要的应用，如生物恐怖主义监测。 公共卫生关系：在医疗机构运行的计算机化系统，可以提供连续的，积极的监测和及时识别潜在的安全问题后，新的药物引入处方集是非常可取的。这样的系统可以导致更安全的药物使用政策，更具成本效益的处方决策，更好的医疗保健，以及更早地发现药物不良反应（ADR）。这种技术对改善国家药物监测系统的影响将是显而易见的，因为ADR会使患者的医疗状况复杂化，增加发病率并导致死亡（美国每年约有7，000例死亡归因于ADR）。