Director's Update: November 11, 2003
Clinical trials are a cornerstone of cancer research. Through this framework, we move promising new cancer interventions from the laboratory into clinical studies, and then into the general health care setting. Almost every new treatment we use today, preventive measure that is widely recommended, and innovative early detection strategy was, at one time, tested in a clinical trial with cancer patients or those at risk for cancer. Many of these studies have been conducted through the Community Clinical Oncology Program (CCOP) and the Clinical Trials Cooperative Groups, at the National Cancer Institute's (NCI's) Cancer Centers throughout the country, or here on the National Institutes of Health (NIH) campus at the Warren Grant Magnuson Clinical Center. These centers, groups, and programs continue to be integral parts of NCI's comprehensive clinical trials program. And, this year, we celebrate milestone anniversaries for two of these research programs: the 20th anniversary of CCOP and the 50th anniversary of the NIH Clinical Center. The collective efforts of all of these programs have brought us many of our current successes against cancer and promise to deliver many more.
As NCI commemorates the creation of CCOP this month, we are joined in this celebration by the more than 4,000 community physicians in private practices and 403 hospitals across the nation that comprise this productive collaboration, as well as the hundreds of patients participating in CCOP clinical trials. Fully one-third of those in NCI-sponsored treatment clinical trials today have been accrued by a community physician. Through this program, CCOP physicians are assisting in a vital effort by bringing new cancer treatment options into their communities. This program represents cancer research at the grassroots level.
With its broad, national reach, as well as its demonstrated ability to recruit patients and deliver cancer research interventions, CCOP is a valuable resource for cancer prevention trials. In 1998, the Breast Cancer Prevention Trial (BCPT) was the first large-scale prevention trial to employ the CCOP network, testing the effectiveness of tamoxifen as a chemopreventive agent in more than 13,000 women at heightened risk for breast cancer. This landmark trial revealed that tamoxifen could reduce breast cancer risk by half and proved for the first time that chemoprevention could be an effective strategy. BCPT paved the way for other large-scale prevention studies, such as the Prostate Cancer Prevention Trial (PCPT), which reported earlier this year that finasteride lowers the risk for prostate cancer in men age 55 and older. Ongoing prevention trials via CCOP include the Study of Tamoxifen and Raloxifene (STAR) trial (a 19,000-woman trial comparing the effectiveness of these drugs for preventing breast cancer), the Selenium and Vitamin E Cancer Prevention Trial (or SELECT, a 32,400-man study exploring whether these substances can prevent prostate cancer), and a study testing the effectiveness of selenium in preventing second tumors in people with lung cancer.
Clinical trials conducted by NCI staff are also a vital component of the cancer clinical trials program. Conducting trials at the NIH Clinical Center - a research health care facility like no other in the world - NCI clinical researchers use groundbreaking research protocols to treat patients from around the country. The Clinical Center's unique environment merges basic and clinical research - with bench scientists often working down the hall from their clinical counterparts.
When the Clinical Center opened five decades ago, people diagnosed with a cancer that could not be surgically removed usually had a poor outcome. NCI teams collaborating at the Clinical Center provided the first proof that cancer could be successfully treated using other approaches. Treatments developed by NCI researchers can now cure the majority of childhood cancers, allowing young patients with cancer to survive their disease and lead long, full lives. And NCI researchers at the Clinical Center discovered and tested the first effective treatment for Hodgkin's disease. Today, the 235 NCI-sponsored cancer clinical trials at the Clinical Center are pursuing clinical applications of genomics and proteomics, molecularly targeted therapies, and immunotherapies for cancer, such as immune-directed therapy against melanoma.
NCI's Clinical Trials Cooperative Groups are also a major component of the cancer clinical trials program. These Groups carry out hundreds of large, multicenter treatment clinical trials involving approximately 25,000 patients per year. They also work with smaller clinical trial networks of Cancer Centers that conduct many of the earlier phase clinical trials with investigational drugs.
The relationship among the various components of the clinical trials program underpins our ability to develop new interventions against cancer. For example, every Cancer Center is a participant in at least one Cooperative Group, and Cooperative Groups serve as research bases for the CCOPs, developing and implementing the trials in which the CCOPs participate. This relationship has enabled the development of many new treatment agents over the years, including paclitaxel (for breast and ovarian cancers), the molecularly targeted agents Herceptin® (for breast cancer) and Gleevec® (for chronic myelogenous leukemia and gastrointestinal stromal tumors), and the hormonal therapy letrozole (for breast cancer).
Through clinical trials, we have made remarkable progress in our ability to prevent, diagnose, and treat cancer. Such progress continues to contribute to improved survival and quality of life for those diagnosed with cancer. These advances, however, would never have been possible without the contributions of dedicated physicians, nurses, and other health care professionals - at the NIH Clinical Center, in private practices and hospitals throughout the nation, in academia, and in industry - who continue to work toward ending the suffering and death due to cancer. It also would not have been possible without the tens of thousands of people who volunteer to participate in prevention, treatment, symptom management, and palliative care clinical trials. These heroes quite literally put their lives in the hands of cancer researchers because they believe they will receive the best care available by participating in clinical trials. Their trust is one that we hold sacred.
Despite the demonstrated contributions and successes of the clinical trials program, we need to further streamline clinical studies by removing the barriers to progress and creating and implementing tools and strategies that will enable scientists to rapidly transfer promising research discoveries into clinical and public health interventions. We already are making progress toward this objective. For example, the creation of the Cancer Trials Support Unit has helped to simplify the administration of clinical trials, making it easier for physicians and their patients to participate in NCI-supported clinical trials. Additional new informatics tools are helping to improve reporting on NCI-supplied investigational drugs, and ensure clinical trial safety.
Improving the speed and efficiency with which cancer clinical trials are conducted will be an important priority for NCI over the coming years. Drs. James H. Doroshow and Howard Fine will be taking the lead role in this effort. NCI is now formulating a large-scale initiative aimed at developing and deploying an integrated clinical trials system to accelerate the development of interventions and ensure that those interventions are efficiently incorporated into the care of all who need them. We will continue to keep you informed about this effort.
Andrew C. von Eschenbach, M.D.
Director, National Cancer Institute
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