Clinical Trials Cooperative Group Program
CTEP supports 11 organizations conducting cancer treatment trials through the Clinical Trials Cooperative Group Program. Emphasis is placed on the development and conduct of large, multicenter, randomized phase 3 studies. The program’s mission encompasses a wide variety of investigational efforts.
Cooperative Groups consist of networks of researchers who develop and conduct cancer treatment clinical trials. The Clinical Trials Cooperative Group Program reaches scientists and patients throughout the nation.
- In fiscal year 2010, of all the new patients accrued to CTEP-supported treatment trials, over 23,000 patients were enrolled into Cooperative Group studies
- About 12,000 new patients are evaluated in correlative laboratory studies each year, and many times that number receive follow-up evaluations
- Thousands of investigators participate in Cooperative Group protocols
Each Cooperative Group receives support so that it can generate trials compatible with its particular areas of interest and expertise as well as collaborate with other Cooperative Groups and organizations in clinical trials. Unlike most other NIH cooperative clinical trials efforts, funding for NCI Cooperative Groups is not linked to a specific clinical trial.
Clinical Trials Cooperative Groups
CTEP is currently using the U10 mechanism to fund the following 11 groups via cooperative agreements:
- American College of Surgeons Oncology Group (ACOSOG)
- Cancer and Leukemia Group B (CALGB)
- Children’s Oncology Group (COG)
- Eastern Cooperative Oncology Group (ECOG)
- European Organization for Research and Treatment of Cancer (EORTC)
- Gynecologic Oncology Group (GOG)
- National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
- National Surgical Adjuvant Breast and Bowel Project (NSABP)
- North Central Cancer Treatment Group (NCCTG)
- Radiation Therapy Oncology Group (RTOG)
- Southwest Oncology Group (SWOG)
For over 50 years, the NCI Clinical Trials Cooperative Group Program has conducted large scale cancer clinical trials across the nation, with successful completion of many important trials that have led to new treatments for cancer patients. On average, more than 25,000 patients and thousands of clinical investigators participate in the program's clinical trials annually.
Over time, however, oncology has evolved into a more molecularly-based discipline including genetic sub-classification of tumors and individualized treatments, and there are immense scientific opportunities to be explored. To help the NCI ensure that the Cooperative Groups are optimally situated and well-prepared to design, enroll and complete state-of-the-art trials for cancer patients, NCI asked the Institute of Medicine (IOM) of the National Academies to review the NCI Clinical Trials Cooperative Group Program to gather independent and expert perspectives on the current state of cancer clinical trials. In April 2010, the IOM issued a report providing a series of recommendations and advice on improving the Program.
NCI is now in the process of implementing a comprehensive approach to transforming its clinical trials system that acknowledges the IOM report recommendations as well as previous reports on the NCI Clinical Trials Cooperative Group Program, such as the Clinical Trials Working Group (CTWG) Report. Input by current stakeholder is also being used to create a highly integrated, national clinical trials network. The IOM report recommended that the adult Cooperative Groups be restructured into a total of no more than four groups. Several Cooperative Groups have already merged in the effort to move forward with this recommendation http://www.cancer.gov/ncicancerbulletin/121311/page8. Information on NCI's progress and ongoing activities related to transforming the NCI Clinical Trials Cooperative Group Program is available at: http://transformingtrials.cancer.gov/initiatives/overview.
Jeffrey S. Abrams, M.D., has led the Cancer Therapy Evaluation Program (CTEP) since June 2007. Dr. Abrams came to CTEP in 1993 when he joined as a clinical research scientist to oversee the breast cancer treatment trials portfolio and participate in clinical trials at the NIH Clinical Center and the National Naval Medical Center. More…