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Standardization and Pre-trial Quality Control

  • Chapter
Clinical Trials in Osteoporosis

Abstract

Before initiating a clinical trial the sponsor must be assured that the equipment and techniques used can adequately answer the research question. In multicenter trials each center may have instruments from different manufacturers, compounding the issues involved in initiating the trial. The investigator needs to be assured that:

  1. 1.

    the instruments and anatomical site chosen are adequate to classify the osteoporotic status of patients on entry to the trial and monitor the anticipated change in BMD or QUS;

  2. 2.

    staff are adequately trained on the equipment to be used;

  3. 3.

    the long-term precision is known within the patient group studied;

  4. 4.

    differences between instruments are known and where necessary a cross-calibration derived;

  5. 5.

    patient radiation doses are known.

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Authors
  1. Derek Pearson
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Editors and Affiliations

  1. Department of Medical Physics, Nottingham City Hospital, Hucknall Road, NG5 1PB, Nottingham, UK

    Derek Pearson BSc, PhD (Clinical Director) (Clinical Director)

  2. Business Development, Bio-Imaging Technologies Inc., 826 Newtown-Yardley Road, 18940, Newtown, PA, USA

    Colin G. Miller BSc, PhD (Vice President) (Vice President)

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© 2002 Springer-Verlag London

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Pearson, D. (2002). Standardization and Pre-trial Quality Control. In: Pearson, D., Miller, C.G. (eds) Clinical Trials in Osteoporosis. Springer, London. https://doi.org/10.1007/978-1-4471-3710-8_4

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  • DOI: https://doi.org/10.1007/978-1-4471-3710-8_4

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-85233-229-7

  • Online ISBN: 978-1-4471-3710-8

  • eBook Packages: Springer Book Archive

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