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Biomarker-Guided Trials

In: Principles and Practice of Clinical Trials

Author

Listed:
  • L. C. Brown

    (UCL Institute of Clinical Trials and Methodology, MRC Clinical Trials Unit)

  • A. L. Jorgensen

    (University of Liverpool, Department of Health Data Science)

  • M. Antoniou

    (F. Hoffmann-La Roche Ltd)

  • J. Wason

    (Newcastle University, Population Health Sciences Institute
    University of Cambridge, MRC Biostatistics Unit)

Abstract

This chapter describes the field of precision or stratified medicine and the role that clinical trials play in the development and validation of markers, particularly biomarkers, to inform management of patients. We begin by defining various types of biomarker and describe the life cycle of a biomarker in terms of discovery, analytical validation, clinical validation, and clinical utility. We provide a detailed overview of the many types of biomarker-guided trial designs that have been described in the literature and then summarize the analytical methods that are often used for biomarker-guided trials. Much of the research process for biomarker-guided trials does not differ markedly from that used for non-biomarker-guided trials but particular attention must be given to selecting the most appropriate trial design given the research question being investigated and we hope that this chapter helps with decisions on trial design and analysis in the biomarker-guided setting.

Suggested Citation

  • L. C. Brown & A. L. Jorgensen & M. Antoniou & J. Wason, 2022. "Biomarker-Guided Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 62, pages 1145-1170, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_168
    DOI: 10.1007/978-3-319-52636-2_168
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