A team from the University of Chicago Medicine Comprehensive Cancer Center has received a five-year, $3.9-million award from the National Cancer Institute to serve as a Lead Academic Participating Site for the newly created National Clinical Trials Network (NCTN). The University of Chicago team received the best possible score in the highly competitive application process.
The new network is designed to improve the speed and efficiency of cancer clinical trials, according to the National Cancer Institute. The NCTN — which will focus on early and late stage clinical trials for adults with cancer — will consist of fewer but larger groups of investigators and will distribute resources in a more effective way.
Lead Academic Participating Site grants, created specifically for the NCTN, will provide scientific leadership in development and conduct of clinical trials in association with the adult clinical trial groups. They will perform preliminary studies to prepare for large-scale testing, conduct related studies to support specific trials, provide mentoring for junior faculty, and help recruit appropriate patients to Network trials, especially those expected to have a significant positive impact on cancer treatment.
The University of Chicago is one of up to 30 lead sites in the United States and the only one in Illinois.
"Our cancer center has a well-deserved reputation for high-impact clinical research and a deep and long-standing commitment to the former cancer cooperative groups that now comprise the NCTN," said Hedy Kindler, MD, associate professor of medicine at the University of Chicago and lead principal investigator for the Chicago site. "This grant will enable us to provide outstanding multidisciplinary scientific and administrative leadership in the design and implementation of innovative and potentially practice-changing clinical trials within the NCTN."
NCTN trials will set the standard for cancer treatment in the US and across the world, Kindler said. The significant recent advances in the basic sciences cannot benefit patients unless new treatments are proven safe and beneficial in the clinical setting.
The NCTN was created to consolidate the National Cancer Institute's clinical trials program. It replaces a 55-year-old system, the NCI National Clinical Trials Cooperative Group Program, with a new, more efficient structure. The network combines many smaller highly specialized groups — focused on areas such as pediatric, breast, bowel or gynecological cancers — into a few large cooperative groups in order to enhance system integration and cooperation.
The NCTN represents "an unmatched effort to integrate and streamline the process of cancer clinical trials research," said James Doroshow, MD, deputy director for clinical and translational research at NCI in a statement released by NCI last month.
The remodeling follows a 2010 report from the Institute of Medicine that recommended significant changes to hasten the initiation and completion of cancer clinical trials. The report stressed four goals:
•Improve the speed and efficiency of the design, launch, and conduct of clinical trials.
•Make optimal use of scientific innovations, such as a common data-management system.
•Improve selection, prioritization, support and completion of clinical trials.
•Expand participation of both patients and physicians.
The new network is also taking steps to standardize the prioritization of new studies and to put in place a unified system — including a central institutional review board that will cover studies conducted by the entire system — to protect research subjects at more than 3,000 clinical trial sites.
"As a national leader in designing, conducting and analyzing all phases of clinical trials, the University of Chicago is well positioned to play a leadership role in the new network," said Michelle Le Beau, PhD, Arthur and Marian Edelstein Professor of Medicine and Director of the University of Chicago Medicine Comprehensive Cancer Center. "Selection as an NCTN Lead Academic Participating Site reflects our commitment, historic leadership and deep experience in conducting clinical trials to evaluate the newest strategies for cancer prevention, diagnosis and treatment."
In another major role, University of Chicago statistician James Dignam, PhD, associate professor of biostatistics, has been named as a principal investigator for the Statistics and Data Management Center of one of the new NCTN groups. Dignam and colleagues will provide statistical and data management support for the newly created NRG Oncology Group. NRG brings together three former clinical trial groups from the NCI Cooperative Group program: the National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group and the Gynecologic Oncology Group.
Clinical trials are central to the development of novel and life-saving cancer detection, prevention or treatment strategies. The conduct of NCI-supported trials involves a complex system of designing, reviewing and initiating studies.