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Translating Molecular Biomarkers into Clinical Assays pp 57–67Cite as

Incorporating Clinical Biomarkers into Clinical Trials

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Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 21))

Abstract

Clinical trials are required for testing the safety and efficacy of new drugs produced by the pharmaceutical industry. These trials also serve to provide information on clinical and survival benefits, prediction of treatment responses, identification of patient subpopulations that will benefit from the drug, and many other important aspects of treatment. Clinical biomarkers are essential tools in these trials that enable these different aspects to be evaluated and defined. However, the incorporation of biomarkers into clinical trials requires a knowledge base that includes understanding the different types of clinical biomarkers, selection of the best biomarkers for the trial, best sample handling and processing practices for the biomarker, validation planning, selection of the best technology platform, and selection of the best laboratory to perform the analysis. This chapter provides an overview of how clinical biomarkers are used in clinical trials and discusses the different aspects of incorporating them into clinical trials.

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Abbreviations

Biomarker :

A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention

Clinical trial :

Research-based studies involving human volunteers that are assigned to receive one or more interventions so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes

Validation :

Confirmation through laboratory testing that the performance characteristics of an assay are suitable and reliable for its intended analytical use

Critical reagent :

Reagents such as antibodies, oligonucleotides, enzymes, or fluorescent molecules that are integral parts of an assay that influence assay performance or quality

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Website References

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  2. www.fda.gov/scienceresearch/specialtopics/runningclinicaltrials

  3. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58

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Author information

Authors and Affiliations

  1. Immunoassay Services, Q2 Solutions, 1600 Terrell Mill Road, Suite 100, Marietta, GA, 30067, USA

    Paul W. Rhyne

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  1. Paul W. Rhyne
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Correspondence to Paul W. Rhyne .

Editor information

Editors and Affiliations

  1. Translational Biomarkers and Personalized Medicine, Edison, New Jersey, USA

    Russell Weiner

  2. MKelley Consulting LLC, West Chester, Pennsylvania, USA

    Marian Kelley

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© 2016 American Association of Pharmaceutical Scientists

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Rhyne, P.W. (2016). Incorporating Clinical Biomarkers into Clinical Trials. In: Weiner, R., Kelley, M. (eds) Translating Molecular Biomarkers into Clinical Assays . AAPS Advances in the Pharmaceutical Sciences Series, vol 21. Springer, Cham. https://doi.org/10.1007/978-3-319-40793-7_6

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