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Guidelines for the Development and Incorporation of Biomarker Studies in Early Clinical Trials of Novel Agents

  1. Author:
    Dancey, J. E.
    Dobbin, K. K.
    Groshen, S.
    Jessup, J. M.
    Hruszkewycz, A. H.
    Koehler, M.
    Parchment, R.
    Ratain, M. J.
    Shankar, L. K.
    Stadler, W. M.
    True, L. D.
    Gravell, A.
    Grever, M. R.
    Biomarkers Task Force, N. C. I. I.

  2. Author Address

    [Grever, Michael R.] Ohio State Univ, Columbus, OH 43210 USA. [Groshen, Susan] Univ So Calif, Los Angeles, CA USA. [Dancey, Janet E.; Dobbin, Kevin K.; Jessup, J. Milburn; Hruszkewycz, Andrew H.; Shankar, Lalitha K.] NCI, Bethesda, MD 20892 USA. [Koehler, Maria] GlaxoSmithKline Inc, Narberth, PA USA. [Parchment, Ralph] NCI, SAIC Frederick Inc, Frederick, MD 21701 USA. [Ratain, Mark J.; Stadler, Walter M.] Univ Chicago, Chicago, IL 60637 USA. [True, Lawrence D.] Univ Washington, Seattle, WA 98195 USA. [Gravell, Amy] Emmes Corp, Rockville, MD USA.;Dancey, JE, MaRS Ctr, Ontario Inst Canc Res, S Tower,101 Coll St,Suite 800, Toronto, ON M5G 0A3, Canada.;janet.dancey@oicr.on.ca
    1. Year: 2010
    2. Date: Mar
  2. Journal: Clinical Cancer Research
    1. 16
    2. 6
    3. Pages: 1745-1755
  4. Type of Article: Article
  5. ISSN: 1078-0432
  1. Abstract:

    The National Cancer Institute (NCI) Investigational Drug Steering Committee (IDSC) charged the Biomarker Task Force to develop recommendations to improve the decisions about incorporation of biomarker studies in early investigational drug trials. The Task Force members reviewed biomarker trials, the peer-reviewed literature, NCI and U. S. Food and Drug Administration (FDA) guidance documents, and conducted a survey of investigators to determine practices and challenges to executing biomarker studies in clinical trials of new drugs in early development. This document provides standard definitions and categories of biomarkers, and lists recommendations to sponsors and investigators for biomarker incorporation into such trials. Our recommendations for sponsors focus on the identification and prioritization of biomarkers and assays, the coordination of activities for the development and use of assays, and for operational activities. We also provide recommendations for investigators developing clinical trials with biomarker studies for scientific rationale, assay criteria, trial design, and analysis. The incorporation of biomarker studies into early drug trials is complex. Thus the decision to proceed with studies of biomarkers should be based on balancing the strength of science, assay robustness, feasibility, and resources with the burden of proper sample collection on the patient and potential impact of the results on drug development. The Task Force provides these guidelines in the hopes that improvements in biomarker studies will enhance the efficiency of investigational drug development. Clin Cancer Res; 16(6); 1745-55. (C) 2010 AACR.

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External Sources

  1. View Full Text
  2. DOI: 10.1158/1078-0432.ccr-09-2167
  3. View record in Web of Science®
  4. WOS: 000278595600008

Library Notes

  1. Fiscal Year: FY2009-2010
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