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.
Public Health Relevance Statement: Public Health Relevance: Medical drugs and devices are regulated by the U.S. Food and Drug Administration (FDA) based on data from multicenter clinical trials. Over the past decade the efficiency of clinical trials has been improved by electronic data capture (EDC) systems. While medical imaging plays an important role in clinical trials, often serving as the basis for study end-points and/or safety evaluations, few if any EDC systems integrate imaging corelab workflows. We propose to create a "cloud-based imaging corelab of the future", where medical images can be interpreted from anywhere in the world, resulting in reduced patient safety risks, shorter trial durations, and lower costs.
NIH Spending Category: Patient Safety
Project Terms: adjudicate; base; bone; Brain; Case Report Form; Cellular Phone; Chicago; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collaborations; Communication; cost; Data; Devices; Diagnostic; Drops; electronic data; Electronic Mail; Electronics; Environment; Evaluation; Future; heart imaging; Human Resources; Image; Image Analysis; Imaging technology; improved; Individual; interest; Internet; Label; Link; Los Angeles; Marketing; Measurement; Medical; Medical Imaging; microbial alkaline proteinase inhibitor; New York; Notification; patient safety; Patients; Pharmaceutical Preparations; Phase; Play; Population Study; Protocols documentation; public health relevance; quality assurance; Quality Control; Randomized; Reporting; Research Personnel; Risk; Role; Safety; Secondary to; Secure; Services; Site; Small Business Technology Transfer Research; Solutions; System; Technology; Text; Time; tool; transmission process; treatment effect; tumor; United States Food and Drug Administration; Vendor
