ICBP will work toward this goal by combining efforts from the entire spectrum of cancer researchers, from wet-lab biologists and computer scientists to epidemiologists and clinicians, through nine integrative biology centers: Massachusetts General Hospital, Dana-Farber Cancer Institute, Massachusetts Institute of Technology, Ohio State University, University Hospital of Cleveland, Duke University, Vanderbilt University Medical Center, Stanford University, and Lawrence Berkeley National Laboratory.  Read more  



Clinical Trial System of Future

The recent voluntary recall of rofecoxib (Vioxx) by Merck & Co., Inc., illustrates all too well the importance of well-designed clinical trials and vigilant surveillance for any new drug or medical product. Some 3 years after FDA approval and widespread use, rofecoxib was found to be associated with a two-fold increased risk of cardiovascular toxicities in people who took the drug for 18 months or longer in a clinical trial to prevent colon adenomas. The recall has resulted in the careful review of any cardiovascular effects of other drugs in the class of drugs known as COX-2 inhibitors.

COX-2 inhibitors have shown tremendous promise in the prevention and treatment of several different cancers. NCI is sponsoring more than 40 clinical trials with the COX-2 inhibitor celecoxib (Celebrex), most of which are phase I and include studies on cancer prevention and treatment. Based on the safety concerns reported in the rofecoxib trials and the possibility that these concerns may extend to other COX-2 inhibitors, such as celecoxib, NCI is rapidly reviewing data from our studies of COX-2 inhibitors with our Data Safety Monitoring Boards (DSMBs), starting with the largest studies with the longest follow-up. And, as appropriate, we have added additional cardiovascular expertise to our prevention and treatment trial DSMBs.

Clinical trials are our most powerful weapons in the war against cancer. And the rofecoxib recall is further affirmation that our patients must be clearly informed about the safety and side effects of any new or experimental treatments or drugs they are taking. It also highlights the need for evolution of our national clinical trials program.  Read more  

The NCI Cancer Bulletin is produced by the National Cancer Institute (NCI). NCI, which was established in 1937, leads the national effort to eliminate the suffering and death due to cancer. Through basic, clinical, and population-based biomedical research and training, NCI conducts and supports research that will lead to a future in which we can identify the environmental and genetic causes of cancer, prevent cancer before it starts, identify cancers that do develop at the earliest stage, eliminate cancers through innovative treatment interventions, and biologically control those cancers that we cannot eliminate so they become manageable, chronic diseases. For more information on cancer, call 1-800-4-CANCER or visit http://www.cancer.gov. NCI Cancer Bulletin staff can be reached at ncicancerbulletin@mail.nih.gov.