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.
Public Health Relevance Statement: Abstract 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.
NIH Spending Category: Bioengineering; Cancer
Project Terms: Academia; American; Applications Grants; Automation; Benchmarking; Best Practice Analysis; Biometrics; Biometry; Biometry and Biostatistics; Biostatistics; Blood Coagulation Factor I; Blood Coagulation Factor One; Blood Factor One; Cessation of life; Clinical; Clinical Research; Clinical Study; Clinical Trials; Clinical Trials, Phase II; Clinical Trials, Unspecified; Coagulation Factor I; Coagulation Factor One; Collection; Computer Programs; Computer software; Data; Data Collection; Death; Drug Approval; Drug Costs; Drugs; Electronics; Evaluation; Factor I; Factor One; Feasibility Studies; Fibrinogen; Food and Drug Administration Drug Approval; Funding; Goals; Grant Proposals; Grants, Applications; HIPAA; Health Insurance Portability and Accountability Act; Hour; Image; Image Analyses; Image Analysis; Industry; Injury; Internet; Kennedy Kassebaum Act; Left; Length; Life; Location; Manuals; Measures; Medical Imaging; Medication; Methods; Metric; Missouri; NIH; National Institutes of Health; National Institutes of Health (U.S.); Outcome; PL 104-191; PL104-191; Participant; Patient Recruitments; Patients; Performance; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Phase 2 Clinical Trials; Phase II Clinical Trials; Procedures; Process; Protocol; Protocol Compliance; Protocols documentation; Public Law 104-191; ROC Analysis; Regulation; Reporting; Research; Research Contracts; Safety; Scanning; Screening procedure; Services; Simulate; Site; Software; Specific qualifier value; Specified; Staging; System; System, LOINC Axis 4; Technology; Testing; Time; Transmission; United States Health Insurance Portability and Accountability Act; United States National Institutes of Health; Universities; WWW; Washington; abstracting; base; clinical investigation; clinical research site; clinical site; computer program/software; cost; drug development; drug/agent; experience; flexibility; image evaluation; image processing; imaging; meetings; non-compliance; open source; performance tests; phase 2 study; phase 2 trial; phase II trial; protocol violation; protocol, phase II; public health relevance; screening; screenings; statistics/biometry; study, phase II; time use; transmission process; web; world wide web
