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Clinical Trials Data Management in the Big Data Era

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Big Data – BigData 2020 (BIGDATA 2020)

Part of the book series: Lecture Notes in Computer Science ((LNISA,volume 12402))

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Abstract

The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP), Clinical Research Pharmacy Coordinating Center (Center) has supported clinical trials for more than four decades. Managing information from clinical trials and published results in the Big Data era presents new challenges and opportunities. These include and are not limited to data attribution, aggregation, adaptability, and prompt analysis. Hence, the Center has created a dynamic application to present a broad understanding of the clinical trials’ achievements. To collect crucial information from clinical trials, this application includes 1) data attribution to identify provenance and to preserve relationships between trials and resulting publications, 2) data normalization to deal with variety of formats and concepts, 3) data aggregation to integrate information from different trials, and 4) data analysis with a friendly interface to consult aggregated information promptly. This work establishes a Semantic Data Model for each clinical trial to create a summary of key information in a machine-readable format, and to enrich each summary with semantic information. In addition, it allows the union of these models to represent a global knowledge source from a set of clinical trials. The organized models offer compatibility and interoperability within and among clinical trials.

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Acknowledgments

This research was supported in part by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Cooperative Studies Program using resources and facilities at the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. The authors thank Zachary Taylor, Kathy Boardman, Heather Campbell, and anonymous reviewers for valuable comments to improve this manuscript. Similarly, we acknowledge Todd A. Conner for his encouragement and relevant comments to improve this work.

Author information

Authors and Affiliations

  1. Veterans Affairs Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, 87106, USA

    Martha O. Perez-Arriaga & Krishna Ashok Poddar

Authors
  1. Martha O. Perez-Arriaga
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  2. Krishna Ashok Poddar
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Corresponding author

Correspondence to Martha O. Perez-Arriaga .

Editor information

Editors and Affiliations

  1. CSIRO, Marsfield, NSW, Australia

    Surya Nepal

  2. Facebook (United States), Menlo Park, CA, USA

    Wenqi Cao

  3. Chungbuk National University, Cheongju, Korea (Republic of)

    Aziz Nasridinov

  4. Fordham University, Bronx, NY, USA

    MD Zakirul Alam Bhuiyan

  5. University of North Texas, Denton, TX, USA

    Xuan Guo

  6. Kingdee International Software Group Co. Ltd., Shenzhen, China

    Liang-Jie Zhang

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Contents are expressed by the authors and do not represent the views of the Department of Veterans Affairs or the United States Government.

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Perez-Arriaga, M.O., Poddar, K.A. (2020). Clinical Trials Data Management in the Big Data Era. In: Nepal, S., Cao, W., Nasridinov, A., Bhuiyan, M.Z.A., Guo, X., Zhang, LJ. (eds) Big Data – BigData 2020. BIGDATA 2020. Lecture Notes in Computer Science(), vol 12402. Springer, Cham. https://doi.org/10.1007/978-3-030-59612-5_14

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  • DOI: https://doi.org/10.1007/978-3-030-59612-5_14

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-59611-8

  • Online ISBN: 978-3-030-59612-5

  • eBook Packages: Computer ScienceComputer Science (R0)

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