We do, in fact, have the knowledge to make significant advances across the cancer care spectrum over the next decade, especially in the area of cancer biomarkers. If we can strategically and systematically apply that knowledge, we can dramatically alter the cancer process, paving the way for early detection and the ability to predict a cancer's biologic virulence - both of which could significantly reduce morbidity and mortality from cancer.

This will be the central issue at a 3-day meeting that begins today in Houston convened by NCI and the Food and Drug Administration (FDA). Leaders in clinical oncology, proteomics, genomics, nanotechnology, imaging, bioinformatics, and other supporting areas will use this meeting to discuss and develop strategies for integrating biomarkers into cancer clinical trials. Incorporating these critically important signals - found in serum, urine, or tissue - into clinical trials will help investigators more quickly determine which patients are likely to respond best to a given treatment and whether the treatments are working, as well as achieve the biologically relevant dose of new therapeutic agents.

The Houston meeting is part of the ongoing development of a multi-pronged effort at NCI to leverage the cancer biomarkers' promise, including a strong basic science portfolio, the Early Detection Research Network (EDRN), and a new program to harmonize and support rational biomarker discovery. This meeting will add the dimension of sound strategies to accelerate biomarkers' integration into cancer clinical trials.

Progress in this area has been swift. Several biomarker tests under investigation for a variety of cancers have shown promise for early detection, and researchers across all sectors are extending these findings, using these biomarkers to identify new therapeutic targets.

EDRN has had remarkable success in its 4-year existence, including the launch last October of a 3-year study to validate an EDRN-created test that looks for biomarkers in urine that indicate bladder cancer recurrence. Biomarker validation and discovery continues to evolve through EDRN-funded laboratories, including approximately $10 million in funding announced late last year for 17 biomarker developmental laboratories. In addition to EDRN, NCI also is funding the development of tools and infrastructure to support biomarker discovery, validation, and development.

Finally, through the Interagency Oncology Task Force (IOTF), NCI is working to streamline regulatory processes that could affect biomarkers' use in clinical trials. An IOTF subgroup, for example, is developing plans for the development of biomarkers in coordination with the FDA's Critical Path Initiative. A special focus of biomarker development for IOTF is the development and integration of imaging as biomarkers, and potentially surrogate endpoints - one of the most promising areas of biomarker research for cancer. And IOTF has formed a new subcommittee to examine the use of biomarkers to determine efficacy and long-term toxicity of agents in prevention trials.

Like Dr. Hartwell and many others, I believe in the promise of biomarker research. It is an important component of an integrated, multifaceted strategy NCI embarked upon 2 years ago to develop new interventions that disrupt or arrest the mechanisms responsible for cancer initiation and progression. We have made important progress in a short time, and I fully expect it to continue.

Dr. Andrew C. von Eschenbach
Director, National Cancer Institute