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Cost-Effective Approach to Managing Laboratory Reference Ranges for Local Laboratories in Clinical Research

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Abstract

The use of a single central laboratory with universal references ranges is not always a viable option in clinical studies; examples are oncology studies where a rapid turnaround of clinical laboratory results is critical. However, the complexities associated with multiple sites, multiple laboratories, and multiple age and sex groups can lead to logistical nightmares across clinical trials and make handling laboratory data one of the most challenging, labor-intensive, and time-consuming tasks for clinical data managers, especially where different laboratories are used for the same patient. Also, evidence suggests that the reference ranges (RRs) used by the local laboratories often create a false sense of precision that is not always supported by science. Managing time-specific, demographic-specific, and site-specific RRs requires significant investment in time and labor. As a result, an alternative approach to management of local laboratory RRs that uses “standard” (sometimes called “published”) ranges has been growing in popularity over the past several years. This article attempts to compare the pros and cons of this approach relative to the historic ways of handling local laboratory RRs. Scientific, operational, and economic perspectives are also presented.

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Author notes

  1. Imogene Grimes PhD

    Present address: Current affiliations: Transtech Pharma Inc, High Point, NC, USA

Authors and Affiliations

  1. Vadim Tantsyura, 68 Judith Drive, Danbury, CT, 06811, USA

    Vadim Tantsyura MS, MA, DrPH(c)

  2. Otsuka Pharmaceutical Company, Rockville, MD, USA

    Imogene Grimes PhD

  3. Target Health Inc, New York, NY, USA

    Jules Mitchel MBA, PhD

  4. Pinacle21/OpenCDISC, Bedminster, NJ, USA

    Sergiy Sirichenko MS

  5. JT Crowe Consulting, Richmond, VA, USA

    Jim Crowe MS

  6. New York Medical College, Valhalla, NY, USA

    Deborah Viola MBA, PhD

Authors
  1. Vadim Tantsyura MS, MA, DrPH(c)
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  2. Imogene Grimes PhD
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  3. Jules Mitchel MBA, PhD
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  4. Sergiy Sirichenko MS
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  5. Jim Crowe MS
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  6. Deborah Viola MBA, PhD
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Corresponding author

Correspondence to Vadim Tantsyura MS, MA, DrPH(c).

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Tantsyura, V., Grimes, I., Mitchel, J. et al. Cost-Effective Approach to Managing Laboratory Reference Ranges for Local Laboratories in Clinical Research. Ther Innov Regul Sci 46, 593–599 (2012). https://doi.org/10.1177/0092861512446333

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  • DOI: https://doi.org/10.1177/0092861512446333

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