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![]() BREAKOUT SESSION 1: Clinical Challenges and Related Software/Informatics Requirements Maturing data-networks and innovative instrumentation can improve clinical decision-making through quantitative integration and informatics. Such synergism will be possible only if data structures and standards permit the integration of conventional clinical data and the information obtained from imaging, other bio sensors, and the clinical application of basic research advances in genomics and gene expression technologies. First steps require an analysis of technical problems in hardware and software, quality assurance matters, privacy and other regulatory concerns, and other uncertainties that impact data integration. How to harmonize data collection so that software tools can have general utility remains a major problem. A critical review of the weaknesses in existing clinical trial infrastructure could provide essential information about current difficulties, and serve to point the way to developing a pathway for advancing quantitative data analysis, data integration and related informatics methods. A clinical trial demonstration project might provide exemplary data for testing software optimization procedures and clinical validation. Ultimately, clinical acceptance of such decision-making tools will require demonstration of value, cost/benefit trade-offs, ease of use, and cultural acceptability.
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