Next-Generation Safety Data Mining System

下一代安全数据挖掘系统

• 批准号: 6684442
• 负责人: DAVID M FRAM
• 金额: $ 38.46万
• 依托单位: LINCOLN TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-06-15 至 2004-12-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6684442
• 关键词: Internet; clinical research; computer graphics /printing; computer program /software; computer system design /evaluation; drug adverse effect; drug interactions; information retrieval; information systems; mathematics; statistics /biometry

DESCRIPTION (provided by applicant): The overall aim of this research is to develop an advanced data mining environment for extracting information relating to the safety of drugs (and other therapeutic products) from large databases of adverse reaction reports. The project builds upon prior research on a first-generation system which has received pilot use at FDA, CDC, and several pharmaceutical companies. This Fast Track proposal focuses on creating a next-generation system that achieves significant breakthroughs along several dimensions: computational and statistical methodology, ease-of-use and ease-of-access, data pre- and post-processing, and results visualization and interpretation. Such a next-generation system is an enabling technology for improved risk management, including early safety signaling and the investigation of drug interactions and adverse event syndromes. In Phase I, feasibility will be established through research in four key areas: (1) performance enhancement to handle larger, more complex problems; 2) results filtering to help with discriminating "interesting" from "uninteresting" results; 3) different baselines for use in comparison studies; and 4) specialized graphics for exploring and interpreting more than two-factor effects. Phase II will create a full-scale prototype of the proposed next-generation safety data mining system and will include several cycles of beta-testing and validation by collaborating statisticians and medical safety officers.

描述(由申请人提供)：这项研究的总体目标是开发一个高级数据挖掘环境，用于从不良反应报告的大型数据库中提取与药物(和其他治疗产品)的安全性有关的信息。该项目建立在先前对第一代系统的研究基础上，该系统已在FDA、CDC和几家制药公司进行试点使用。这项快速通道提案侧重于创建一个在以下几个方面取得重大突破的下一代系统：计算和统计方法、易于使用和易于获取、数据前后处理以及结果可视化和解释。这种下一代系统是改进风险管理的一项使能技术，包括早期安全信号以及药物相互作用和不良事件综合征的调查。 在第一阶段，将通过以下四个关键领域的研究确定可行性：(1)改进性能，以处理更大、更复杂的问题；(2)结果过滤，以帮助区分“有趣”和“无趣”的结果；3)用于比较研究的不同基线；以及4)探索和解释两因素以上影响的专门图表。第二阶段将创建拟议的下一代安全数据挖掘系统的全尺寸原型，并将包括由合作统计学家和医疗安全官员进行几个周期的Beta测试和验证。