Medical Images, HTML5, and Clinical Trial Remote Collaboration

医学图像、HTML5 和临床试验远程协作

• 批准号: 8956516
• 负责人: ROBERT M JUDD
• 金额: $ 74.99万
• 依托单位: HEART IMAGING TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8956516
• 关键词: Brain; Case Report Form; Cellular Phone; Chicago; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Data; Devices; Diagnostic; Drops; Electronic Mail; Electronics; Environment; Evaluation; Future; Health; Human Resources; Image; Image Analysis; Imaging technology; Individual; Internet; Label; Link; Los Angeles; Marketing; Measurement; Medical; Medical Imaging; New York; Notification; Patients; Pharmaceutical Preparations; Phase; Play; Population Study; Protocols documentation; Quality Control; Randomized; Reporting; Research Personnel; Risk; Role; Safety; Secondary to; Secure; Services; Site; Small Business Technology Transfer Research; Solutions; System; Technology; Text; Time; United States Food and Drug Administration; Vendor; X-Ray Computed Tomography; adjudicate; base; bone; cloud based; cost; electronic data; heart imaging; improved; interest; patient safety; quality assurance; tool; transmission process; treatment effect; trial design; tumor

DESCRIPTION (provided by applicant): Medical drugs and devices are regulated by the U.S. Food and Drug Administration (FDA) based on data from multicenter clinical trials. In 2010, U.S. spending on clinical trials was approximately $25 billion. Over the past decade the efficiency of clinical trials has been improved by electronic data capture (EDC) systems, whose use has increased from 38% to 61% from 2006 to 2011. While medical imaging plays an important role in clinical trials, often serving as the basis for study end-points and/or safety evaluations, few f any EDC systems integrate imaging corelab workflows such as image quality assurance, site queries, and reporting of end-point analyses. Heart Imaging Technologies (Heart IT) developed the world's first "zero footprint" medical image viewer, WebPAX, which displays diagnostic-quality images in a bare bones web browser. Recently, several leading vendors of EDC systems have invited HeartIT to enter into partnerships to integrate WebPAX image uploading and viewing into their EDC products. In this project we propose to create a "cloud-based imaging corelab of the future" that provides support for all imaging corelab activities. We propose that by moving imaging corelabs out of their traditional "brick-and-mortar" environments and into the "cloud", medical images can be interpreted from anywhere in the world within minutes rather than weeks. Moving corelabs to "the cloud" will not only improve corelab workflows, but will also improve communication between the corelab and the other clinical trials stakeholders such as the CRO, the data safety and monitoring board (DSMB), the sponsor, and the FDA. In addition, making images available rapidly will enable new trial designs that reduce site-to-site variability of the study population, thereby reducing the number of patients needed to detect treatment effects, trial durations, and trial costs.

描述（申请人提供）：医疗药品和器械由美国食品药品监督管理局（FDA）根据多中心临床试验数据进行监管。2010年，美国在临床试验上的支出约为250亿美元。在过去的十年中，电子数据采集（EDC）系统提高了临床试验的效率，其使用率从2006年的38%增加到2011年的61%。虽然医学成像在临床试验中发挥着重要作用，通常作为研究终点和/或安全性评价的基础，但很少有EDC系统集成成像核心实验室工作流程，如图像质量保证、研究中心查询和终点分析报告。Heart Imaging Technologies（Heart IT）开发了世界上第一个“零足迹”医学图像查看器WebPAX，它可以在一个简单的Web浏览器中显示诊断质量的图像。最近，几家领先的EDC系统供应商邀请HeartIT建立合作伙伴关系，将WebPAX图像上传和查看集成到他们的EDC产品中。在这个项目中，我们建议创建一个“基于云的未来成像核心实验室”，为所有成像核心实验室的活动提供支持。我们建议， 将成像核心实验室从传统的“砖和灰泥”环境转移到“云”中，可以在几分钟而不是几周内从世界任何地方解读医学图像。将核心实验室迁移到“云”不仅可以改善核心实验室的工作流程，还可以改善核心实验室与其他临床试验利益相关者（如CRO、数据安全和监测委员会（DSMB）、申办者和FDA）之间的沟通。此外，快速提供图像将使新的试验设计能够减少研究人群的站点间差异，从而减少检测治疗效果所需的患者数量、试验持续时间和试验成本。