Electronic Image Trial Management System

描述（由申请人提供）：FDA药物批准的延迟以失去的生命（估计在过去几十年中有数十万人）和最终批准的药物给美国公民增加的成本来衡量。导致药物审批延迟的一个因素是，将医学图像（即CT、MR等）从世界各地的远程临床成像站点传输到图像分析中心或合同研究组织（CRO），以手动筛选图像数据，以检测协议和FDA合规性错误，广泛使用耗时且容易出错的手动方法。在典型的临床药物试验中，由于方案依从性或传输错误，10%至50%的患者数据可能被排除在外。这导致不必要的延误，并可能需要增加患者招募。FDA认为，数据收集、提交和分析的自动化是简化临床试验的关键一步，并且正在考虑要求所有新药申请的临床研究数据都以电子方式提交。

DESCRIPTION (provided by applicant): Delays in FDA drug approval are measured in lost lives (estimated to be hundreds of thousands over the last few decades) and increased costs to U.S. citizens for drugs that are eventually approved. One factor contributing to the delay in drug approvals is the widespread use of time-consuming and error-prone manual methods to deliver medical images (i.e. CT, MR, etc.) from remote clinical imaging sites, located throughout the world, to an image analysis center or Contract Research Organization (CRO) for manual screening of image data to detect protocol and FDA compliance errors. In a typical clinical drug trial, 10% to 50% of patient data may be excluded due to protocol compliance or transmission errors. This results in unnecessary delays and a potential need for increased patient recruitment. The FDA believes automation of data collection, submission and analysis is a critical step toward streamlining clinical trials and is considering a requirement that all clinical study data for new drug applications be submitted electronically. The assumption that electronic automation will reduce time, errors, and cost for drug development has not been proven. While these assumptions seem reasonable based on clinical experience, there is little direct evidence or data comparing electronic submission to current methods of data and image collection. Our long term goal is to replace the manual method with a new, open source electronic Imaging Trial Management System that helps reduce the time for FDA drug approval. The objective of this application is to develop a baseline electronic Imaging Trial Management System and to evaluate its performance for image data transfer, image protocol compliance, and FDA regulatory compliance in a simulated imaging trial. The central hypothesis of this application is that an open source, FDA-compliant, electronic Imaging Trial Management System is feasible for automated electronic delivery of medical image data between a remote imaging site and a centralized image analysis center or CRO. This pilot grant application has two specific aims: 1) Develop an electronic Imaging Trial Management System that includes full FDA and HIPAA compliance; and 2) Perform a feasibility study to evaluate the electronic Imaging Trial Management System. An electronic Imaging Trial Management System will incorporate existing technology from Washington University in St. Louis and VirtualScopics, Inc. Washington University will provide automated procedures with built in error checking that have been proven in multiple image-based NIH funded trials. VirtualScopics will provide key regulatory-compliance management (FDA) and sponsor reporting components used on a routine basis in multiple clinical trials. The integrated electronic Imaging Trial Management System will be deployed both to VirtualScopics and Washington University for feasibility testing. Washington University will serve as a remote imaging site and will transmit image data of test phantoms and existing de-identified imaging studies. VirtualScopics will serve as the CRO and receive, distribute, measure, and review the image data for protocol violations. Two metrics will be used to test the performance of the electronic Imaging Trial Management System: (1) the time from image capture to when the images are measured or reviewed at the central processing center; and (2) the number of imaging protocol and FDA compliance errors detected in each stage of the process. Because this is a feasibility test, the study director will insert errors unknown to the study participants to test the Image Trial Management System's ability to detect and report such errors. This research is significant since no commercial products currently exist that automate the complete data collection process from image acquisition to submission of results. A flexible, open source, electronic Imaging Trial Management System (ITMS) including full FDA and HIPAA regulatory compliance functionality and sponsor reporting will fill this gap and provide a new commercial product/service. PUBLIC HEALTH RELEVANCE: Delays in FDA drug approval are measured in lost lives (estimated to be hundreds of thousands over the last few decades) and increased costs to U.S. citizens for drugs that are eventually approved. One factor contributing to the delay in drug approvals is the widespread use of time-consuming and error-prone manual methods to deliver medical images (i.e. CT, MR, etc.) from remote clinical imaging sites, located throughout the world, to an image analysis center or Contract Research Organization (CRO) for manual screening of image data to detect protocol and FDA compliance errors. In a typical clinical drug trial, 10% to 50% of patient data may be excluded due to protocol compliance or transmission errors. This results in unnecessary delays and a potential need for increased patient recruitment. The FDA believes automation of data collection, submission and analysis is a critical step toward streamlining clinical trials and is considering a requirement that all clinical study data for new drug applications be submitted electronically. The assumption that electronic automation will reduce time, errors, and cost for drug development has not been proven. While these assumptions seem reasonable based on clinical experience, there is little direct evidence or data comparing electronic submission to current methods of data and image collection. Our long term goal is to replace the manual method with a new, open source electronic Imaging Trial Management System that helps reduce the time for FDA drug approval. The objective of this application is to develop a baseline electronic Imaging Trial Management System and to evaluate its performance for image data transfer, image protocol compliance, and FDA regulatory compliance in a simulated imaging trial. The central hypothesis of this application is that an open source, FDA-compliant, electronic Imaging Trial Management System is feasible for automated electronic delivery of medical image data between a remote imaging site and a centralized image analysis center or CRO. This pilot grant application has two specific aims: 1) Develop an electronic Imaging Trial Management System that includes full FDA and HIPAA compliance; and 2) Perform a feasibility study to evaluate the electronic Imaging Trial Management System. An electronic Imaging Trial Management System will incorporate existing technology from Washington University in St. Louis and VirtualScopics, Inc. Washington University will provide automated procedures with built in error checking that have been proven in multiple image-based NIH funded trials. VirtualScopics will provide key regulatory-compliance management (FDA) and sponsor reporting components used on a routine basis in multiple clinical trials. The integrated electronic Imaging Trial Management System will be deployed both to VirtualScopics and Washington University for feasibility testing. Washington University will serve as a remote imaging site and will transmit image data of test phantoms and existing de-identified imaging studies. VirtualScopics will serve as the CRO and receive, distribute, measure, and review the image data for protocol violations. Two metrics will be used to test the performance of the electronic Imaging Trial Management System: (1) the time from image capture to when the images are measured or reviewed at the central processing center; and (2) the number of imaging protocol and FDA compliance errors detected in each stage of the process. Because this is a feasibility test, the study director will insert errors unknown to the study participants to test the Image Trial Management System's ability to detect and report such errors.