Abstract
Two new emerging sub-domains in biomedical informatics – translational bioinformatics and clinical research informatics – provide information technology (IT) solutions supporting research – whether basic, clinical or translational research. The aim of the so-called “translational research” is to improve the continuum between research and care and to facilitate personalized medicine. Translational research requires better cooperation between basic research centers, healthcare facilities, clinical research and public health organizations and therefore better integration of information systems of these sectors.
This chapter presents the main characteristics of information systems used in the biomedical research domain and especially focuses on the information technology (IT) infrastructures developed to better integrate clinical care and research activities. The opportunities for the different stakeholders and the main challenges faced while developing such infrastructures are presented. The technical challenges are especially addressed (semantic interoperability, data integration, solutions ensuring data quality, data security and patient privacy, data mining). The potential of EHRs and PHRs to improve patient recruitment, conduct feasibility studies, refine inclusion/exclusion criteria, enhance safety data and, in general, to inform basic and clinical research is addressed. Examples of key national or international information technology (IT) infrastructures dedicated to translational research are shortly described.
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Notes
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This guide, edited in May 2007 by the “Food and Drug Administration” (FDA) and the U.S. Department of Health and Human Services supplements the guidance for industry entitled “21 CFR Part 11” (Electronic Records; Electronic Signatures – Scope and Application), dated August 2003 and the Agency's international harmonization efforts (E6 Good Clinical Practice) when applying these guidances to source data generated at clinical study sites.
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Daniel, C., Albuisson, E., Dart, T., Avillach, P., Cuggia, M., Guo, Y. (2014). Translational Bioinformatics and Clinical Research Informatics. In: Venot, A., Burgun, A., Quantin, C. (eds) Medical Informatics, e-Health. Health Informatics. Springer, Paris. https://doi.org/10.1007/978-2-8178-0478-1_17
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