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Pragmatic Trials and New Informatics Methods to Supplement or Replace Phase IV Trials

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Personalized and Precision Medicine Informatics

Part of the book series: Health Informatics ((HI))

Abstract

Given the importance of clinical trials (CT) for the approval of new drugs, and the many current obstacles to CT execution, there is an urgent need for CT improvement. This chapter discusses pragmatic trials and other informatics-enabled enhancements to Phase IV CT that completely change the original definitions of CT and may be seen as full replacements to Phase IVs. These developments are important for reducing costs and time-lines for the CT process, reducing risk of withdrawal from the market, and they are also useful for drug repurposing. Importantly, the future of Phase IV CTs is one that relies heavily on data collected via the EHR enabling a continuous and individualized Phase IV trial model. The EHR thus is a foundation to a continuous pragmatic Phase IV registry and a key tool in support of precision medicine.

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Author information

Authors and Affiliations

  1. Department of Biostatistics and Medical Informatics, School of Medicine and Public Health, Department of Industrial and Systems Engineering in the College of Engineering, Clinical/Health Informatics, UW Institute for Clinical and Translational Research, University of Wisconsin Madison, Madison, WI, USA

    Eneida Mendonca

  2. Department of Biostatistics and Medical Informatics, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA

    Umberto Tachinardi

  3. UW Institute for Clinical and Translational Research, University of Wisconsin-Madison, Madison, WI, USA

    Umberto Tachinardi

  4. UW Health, University of Wisconsin-Madison, Madison, WI, USA

    Umberto Tachinardi

Authors
  1. Eneida Mendonca
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  2. Umberto Tachinardi
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Corresponding author

Correspondence to Umberto Tachinardi .

Editor information

Editors and Affiliations

  1. Pharmaceutical Care & Health Systems, University of Minnesota Pharmaceutical Care & Health Systems, Minneapolis, MN, USA

    Terrence Adam

  2. Institute for Health Informatics, University of Minnesota, Minneapolis, MN, USA

    Constantin Aliferis

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Mendonca, E., Tachinardi, U. (2020). Pragmatic Trials and New Informatics Methods to Supplement or Replace Phase IV Trials. In: Adam, T., Aliferis, C. (eds) Personalized and Precision Medicine Informatics. Health Informatics. Springer, Cham. https://doi.org/10.1007/978-3-030-18626-5_14

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  • DOI: https://doi.org/10.1007/978-3-030-18626-5_14

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-18625-8

  • Online ISBN: 978-3-030-18626-5

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