SBIR Phase I: Efficient Comparative Effective Research Tools In Real Time Environment

这个小型企业创新研究(SBIR)第一阶段项目将专注于医疗保健研究人员利用临床和生物分子数据进行比较有效性研究(CER)和循证医学(EBM)。通过二次使用来自电子病历系统(EMR)的卫生保健数据，以及通过使用基因组生物标志物，可以显著提高卫生保健质量。如今，使用电子病历中的回溯性数据进行医疗保健研究的当前流程需要IT专业人员组成的团队，并且非常容易出错。此外，这些系统不容易利用从基因组和遗传筛选中获得的信息。该项目的两个目标是：1)创建一个可供临床研究人员使用的自助式、高效的医疗保健数据查询工具；2)创建一个数据集市，使用可为生物标记物数据带来上下文的知识引擎将EMR数据与分子数据集成在一起。最终交付的产品将是一个支持个性化药物(PM)整个生命周期的系统；直接影响个别患者护理的追溯分析、验证和报告生成。该项目的更广泛影响/商业潜力是重大的，因为它利用了医疗保健的两个趋势--患者临床数据数字化和测序和微阵列技术的增加--以提供个性化药物。该项目中提到的技术创新的商业化将使研究人员和临床医生能够生成循证医学、CER和PM报告，最终目标是改善患者的结果。利用CER中的历史患者数据从总体上消除医疗保健系统中的无效疗法，再加上利用遗传信息创建更个性化的医疗保健模式，将把宝贵的医疗保健资金集中在针对个人优化的有效疗法上。最终，这一工具将吸引医疗保健行业的每一个细分市场，包括临床医生、研究人员、制药公司和保险公司，因为它将提高质量和节省成本。真正的个性化医疗将会到来。

This Small Business Innovation Research (SBIR) Phase I project will focus on the enablement of comparative effectiveness research (CER) and evidence based medicine (EBM) by health care researchers utilizing both clinical and biomolecular data. The quality of health care can be significantly improved through the secondary use of health care data from electronic medical records systems (EMR) and also through the use of genomic biomarkers. Today, the current process of health care research using retrospective data from EMR requires a team of IT professionals and is very error prone. Further, these systems do not readily utilize the information that is available from genomic and genetic screens. The two goals of this project are: 1) to create a self-service, highly efficient query tool for health care data that can be utilized by clinical researchers and 2) to create a data mart that integrates EMR data with molecular data using a knowledge engine that brings context to biomarker data. The ultimate deliverable will be a system enables the entire life cycle of personalized medicine (PM); retrospective analysis, validation and report generation that directly impacts the care of the individual patient.The broader impact/commercial potential of this project is significant because it capitalizes on two trends in health care - digitizing patient clinical data and the increased use of sequencing and microarray technology - in order to provide Personalized Medicine. The commercialization of the technical innovations referenced in this project will enable researchers and clinicians to generate EBM, CER and PM reports with the ultimate objective of improving patient outcomes. Leveraging historical patient data in CER to eliminate ineffective therapies from the health care system in general coupled with utilizing genetic information to create a more personalized model of health care will focus precious health care dollars on effective therapies optimized for the individual. Ultimately, this tool will be appealing to every segment of the health care industry including clinicians, researchers, pharmaceutical companies, and insurance companies due to the increases in quality and cost savings that will be created. True Personalized Medicine will have arrived.