Medical Images, HTML5, and Clinical Trial Remote Collaboration

医学图像、HTML5 和临床试验远程协作

基本信息

批准号：
8522583
负责人：
ROBERT M JUDD
金额：
$ 15万
依托单位：
HEART IMAGING TECHNOLOGIES, LLC
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-01 至 2015-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8522583
关键词：
Brain Case Report Form Cellular Phone Chicago Clinical Trials Clinical Trials Data Monitoring Committees Clinical Trials Design Collaborations Communication Data Devices Diagnostic Drops Electronic Mail Electronics Environment Evaluation Future 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 adjudicate base bone cost electronic data heart imaging improved interest microbial alkaline proteinase inhibitor patient safety public health relevance quality assurance tool transmission process treatment effect tumor

项目摘要

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（由申请人提供）：根据多中心临床试验的数据，美国食品药品监督管理局（FDA）监管了医疗药物和设备。 2010年，美国在临床试验上的支出约为250亿美元。 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分析。心脏成像技术（Heart IT）开发了世界上第一个“零脚印”医疗图像查看器WebPax，它在裸露的骨头网络浏览器中显示诊断质量的图像。最近，EDC系统的一些领先供应商邀请HeartIt建立合作伙伴关系，以将WebPax图像上传和查看到其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Corelab”，为所有成像Corelab活动提供支持。我们通过将成像曲线列出从传统的“实体”环境中移出到“云”中，可以在几分钟而不是几周内从世界任何地方解释医学图像。将Corelabs移至“云”不仅会改善Corelab的工作流程，而且还将改善Corelab与其他临床试验利益相关者（例如CRO，数据安全和监测委员会（DSMB）），赞助商和FDA之间的沟通。此外，制作图像迅速将实现新的试验设计，以减少研究人群的现场变异性，从而减少检测治疗效果，试验时间和试验费用所需的患者数量。