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NCI and FDA jointly sponsored a meeting February 2-4 at M.D. Anderson Cancer Center in Houston to develop new strategies for integrating biomarkers into cancer clinical trials. Participants focused on how best to speed discovery of biomarkers and translate their use into clinical practice.

NCI Director Dr. Andrew C. von Eschenbach noted that the oncology field is poised for a quantum leap that may change the outcome of the cancer process, in which normal cells become malignant ones.

Biomarkers are characteristics that are measured and evaluated as indicators of normal and disease processes or responses to therapy. For example, prostate-specific antigen and CA-125 are biomarkers for prostate and ovarian cancer, respectively.

As researchers learn more about cancer at the molecular level, biomarkers could be used to:

• Define homogeneous disease subgroups at the molecular level
• Understand specific disease pathways
• Select patients based on identification of drug target
• Demonstrate drug efficacy that might otherwise have been missed in a study population
• Conduct clinical trials more efficiently
• Expedite FDA approval of drugs that benefit patients in a cost-effective manner

The sequencing of the human genome and emergence of proteomics has spurred the search for biomarkers, but the field has not developed as quickly as expected, according to Dr. Leland Hartwell, president, Fred Hutchinson Cancer Research Center, especially with regard to the discovery of protein biomarkers. Dr. Hartwell noted that broad-based initiatives with teams of scientists supported by large-scale information technologies will be needed to successfully meet the biomarker discovery challenge in proteomics.

The speakers described the current technical challenges in the field, particularly the need to identify and quantify the many proteins affected in cancer. Many of the speakers also called for standardized methods, new technologies, and common reagents to identify and validate potential biomarkers to ensure comparability across laboratories.

Collecting, archiving, and annotating human blood, serum, and tumor tissue samples is a current challenge. Wide variability in collection techniques and annotation methods is a major obstacle. Participants agreed that common databases are needed to enable the best use of available data.

Dr. Anna Barker, NCI deputy director for Advanced Technologies and Strategic Partnerships, ended the meeting, noting that, "The development of biomarkers for integration into clinical trials is both a scientific and regulatory challenge. Therefore, it is gratifying that the FDA has participated so fully in this meeting, as advances in science can inform biomarker development through FDA's Critical Path Initiative."