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Standardization and Pretrial Quality Control

  • Chapter
Clinical Trials in Osteoporosis

Part of the book series: Clinical Trials ((CLINICAL))

  • 731 Accesses

Abstract

Before initiating a clinical trial, the sponsor must be assured that the equipment and techniques used can adequately answer the research question. In multicentre trials, each centre might have instruments from different manufacturers, compounding the issues involved in initiating the trial. The investigator must be assured of the following:

  1. 1.

    The instruments and anatomical site chosen are adequate to classify the osteoporotic status of subjects on entry to the trial and monitor the anticipated change in bone mineral density (BMD) or quantitative ultrasound (QUS)

  2. 2.

    Staff are adequately trained on the equipment to be used

  3. 3.

    Long-term precision is known within the subject group studied

  4. 4.

    Differences between instruments are known and, as necessary, a crosscalibration is derived

  5. 5.

    Subjects radiation doses are known.

The aim of this chapter is to summarize the equipment tests required before establishing a clinical trial to reassure the investigator that each centre is adequately prepared to begin clinical work. It will cover the following points:

  1. 1.

    Differences between dual energy X-ray absorptiomerty (DXA) instruments or ultrasonometers

  2. 2.

    The choice of phantom for crosscalibration

  3. 3.

    The review of daily quality control (QC) before the trial commences

  4. 4.

    Accuracy

  5. 5.

    Precision: both long-term and short-term precision, in vitro and in vivo

  6. 6.

    Crosscalibration and standardized BMD

  7. 7.

    The radiation dose.

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Author information

Authors and Affiliations

  1. Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, UK

    Dr Derek Pearson

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  1. Dr Derek Pearson
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Editors and Affiliations

  1. Medical Physics & Clinical Engineering Department, Nottingham University Hospitals NHS Trust, Nottingham, UK

    Derek Pearson BSc, PhD (Joint Service Manager) (Joint Service Manager)

  2. Medical Affairs, Bio-Imaging Technologies Inc., Newtown, PA, USA

    Colin G. Miller PhD, FICR (Sr. Vice President) (Sr. Vice President)

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© 2007 Springer-Verlag London Limited

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Pearson, D. (2007). Standardization and Pretrial Quality Control. In: Pearson, D., Miller, C.G. (eds) Clinical Trials in Osteoporosis. Clinical Trials. Springer, London. https://doi.org/10.1007/978-1-84628-587-5_4

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  • DOI: https://doi.org/10.1007/978-1-84628-587-5_4

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-84628-389-5

  • Online ISBN: 978-1-84628-587-5

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