As many of the impressive research findings presented at the ASCO annual meeting over the past 5 days demonstrate, we are now deftly applying all that we have learned about the complex biology and molecular underpinnings of cancer. New, targeted agents are showing success against a growing number of cancers, as are combinations of existing therapies with targeted agents and optimized use of standard therapies - all to the benefit of patients.

When such results are combined with those from studies elucidating biological and molecular factors that can guide treatment, we have convincing evidence that clinical oncology is in the midst of a revolution - a dramatic shift that is expanding the clinical oncologist's role from care provider to clinical scientist.

It's important to consider this revolution, however, in the context of another significant event on the horizon: the revamping of the National Cancer Institute (NCI) clinical trials program. During the ASCO meeting, several members of the NCI Clinical Trials Working Group (CTWG) presented a preview of the group's forthcoming recommendations for changing the clinical trials program in a way that will deliver on the promise of everything we have accomplished and learned over the past 3 decades.

The complete recommendations will be presented at the NCI National Cancer Advisory Board (NCAB) meeting in early June, but the ASCO meeting provided an excellent opportunity for members of the cancer research community to hear some of the recommendations' overarching themes and for ASCO leaders to provide feedback on how the organization and its members can participate in this effort.

To be certain, achieving the 2015 goal of eliminating the suffering and death due to cancer depends in large part on clinical trials generating the knowledge required to allow clinical oncologists to provide personalized medicine. At the same time, through well-designed clinical trials, the delivery itself will become a discovery model. Clinical oncologists will become more involved in the clinical trials process, integrating tools such as gene microarrays, proteomics, and imaging into the delivery of care, thus driving discovery by allowing us to further unravel the mechanisms of disease and response to treatment.

This care model plays a critical role in the approach being recommended by CTWG, which recognizes that all those involved in the clinical research enterprise - the NCI-designated Cancer Centers, Cooperative Groups, Community Clinical Oncology Programs (CCOPs), and the NCI Intramural Program - must work not in silos, but cooperatively, so we can seamlessly integrate knowledge into practice.

Among other things, the recommendations seek to increase the transparency of the clinical trials process while expanding the participation of all stakeholders in conducting trials and making key decisions, particularly on issues such as which clinical trials should be sponsored.

As we anticipate development of an implementation plan for the CTWG recommendations, we will draw on the considerable strengths of the NCI-supported clinical research programs with minimal disruption to those conducting the trials. To allow time for full development of the implementation plan, the NCI Executive Committee recently deferred reissuance of an RFA for certain components of the CCOPs. This was done expressly with a provision that provides interim funding for continuing the programs without the need for reapplication. As other components of the oncology clinical trials enterprise come up for funding renewal, it is anticipated that similar actions may be taken to maintain the greatest flexibility while the CTWG recommendations are put into practice.

Mechanisms for continually evaluating the recommendations' implementation will be established so that, if needed, mid-course corrections can be made. Also, an NCAB subcommittee will oversee the recommendations' implementation as well as general oversight of clinical trials.

This is an exciting time with the potential to forever alter the landscape of cancer research and treatment. I encourage all clinical oncologists to respond to the CTWG's recommendations and to find ways to participate in their implementation. Your efforts will pay dividends for decades to come.

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