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U.S. National Institutes of Health
Last Updated: 09/20/12

Plans

  • Convene a Strategy Group (SG) to develop criteria for assessing which markers are ready for further development. The initial focus would be to identify the most pressing clinical questions in a few sites and to identify the most promising markers/techniques based on an extensive review of the literature.
    • The SG will be composed of scientists from academia and industry and NCI staff. Areas of expertise required include clinical oncology, pathology, basic cancer biology, diagnostics technology and assay development, clinical trials methodology, and statistics.
    • SG recommendations will range from the need for workshops, additional research or development of special resources to assay standardization or validation by a clinical trial.
  • Form a Statistical Consulting Group (SCG). (Based on identified needs)
    • Members of the SCG would be chosen based on proposed research projects focused on developing new approaches to efficient study design and on adapting existing statistical approaches to new types of analyses.
    • The SCG will assist investigators in developing study designs.
  • Improve access to human specimens.

    The following are resources that will help improve access to human specimens.

  • Make standardized reagents and control materials available by the:
    • preparation and supply of probes or antibodies that can be used for comparative studies
    • preparation of control materials such as cell lines and/or CBCTR tissue micro-arrays (http://cdp.nci.nih.gov/breast/breast.html)
  • Support validation studies.
    • Make facilities available where reagents/assays for the same marker can be compared on standard tumor sets.
    • Support quality control studies by interested laboratories.
    • Involve professional organizations with interest in standardization.
    • Plan and support clinical trials for validation.