LDL and high-density lipoprotein (HDL) cholesterol levels. In particular, the committee will:

  1. Conduct a review of current approaches to qualifying biomarkers.

  2. Recommend a framework that can be used to rank biomarkers according to the types and quality of evidence, considering context of use for a range of product types.

  3. Demonstrate applications through case studies.

  4. Make ancillary recommendations for the application, enhanced development, and use of risk biomarkers and surrogate endpoints in chronic disease.2

On the basis of this statement of task, the committee undertook its work to address these charges as ensured by the IOM external review process, said committee chair John R. Ball, senior advisor at the American Society for Clinical Pathology.

Committee Process and External Review Process

The IOM convened the committee, which comprised experts from a variety of related fields and was supported by a highly capable staff, said Dr. Ball. The committee met in person four times and had several teleconferences over the course of a year in order to fully develop their charge, set a plan of work, gather relevant evidence, and develop its findings and recommendations. The committee benefited from presentations by outside experts in a workshop format and from comments offered by interested parties. As part of its charge, the committee reviewed alternate biomarker evaluation models; this review can be found in Chapter 2 of the committee’s report (IOM, 2010).

The committee’s report underwent a rigorous external review, which helped focus and clarify their findings and recommendations. Fourteen reviewers participated in this process, and two individuals appointed by the National Research Council and the IOM oversaw the review, according to Dr. Ball.

Early in committee deliberations, Dr. Ball recalled that the committee recognized that “biomarkers are really useful when used carefully.” Biomarkers have served a variety of diverse uses, he noted, which include

  • Discovery and development of medical therapies and products,

  • Comparative effectiveness research,

  • Formation of clinical practice guidelines,

2

The terminology in the statement of task differs in a few ways from the terminology adopted by the committee, which replaced qualification with evaluation in many instances, and risk biomarker with biomarker.



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