Medical Images, HTML5, and Clinical Trial Remote Collaboration

描述(由申请人提供)：医疗药品和设备由美国食品和药物管理局(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，电子数据捕获(EDC)系统提高了临床试验的效率，从2006年到2011年，其使用率从38%增加到61%。虽然医学成像在临床试验中发挥着重要作用，通常用作研究终点和/或安全性评估的基础，但很少有EDC系统集成成像CoreLab工作流程，如图像质量保证、站点查询和终点分析报告。心脏成像技术公司(心脏IT)开发了世界上第一个“零足迹”医学图像查看器WebPAX，它可以在简单的网络浏览器中显示诊断质量的图像。最近，几家领先的EDC系统供应商已邀请HeartIT达成合作伙伴关系，将WebPAX图像上传和查看整合到他们的EDC产品中。在这个项目中，我们建议创建一个“未来的基于云的成像核心实验室”，为所有的成像核心实验室活动提供支持。我们建议通过 将成像核心实验室从传统的“实体”环境转移到“云”环境中，医学图像可以在几分钟内从世界任何地方解释出来，而不是几周。将核心实验室转移到“云”不仅将改善CoreLab的工作流程，还将改善CoreLab与其他临床试验利益相关者之间的沟通，如CRO、数据安全和监测委员会(DSMB)、赞助商和FDA。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到站点的变异性，从而减少检测治疗效果、试验持续时间和试验成本所需的患者数量。

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.