University of Chicago to lead the NRG Oncology Statistics and Data Management Center in NCI’s program for multi-center cancer clinical trials

The University of Chicago will lead the NRG Oncology Statistics and Data Management Center (SDMC), which is receiving six more years of funding from the National Cancer Institute (NCI).

“We are delighted that our institution is providing leadership on coordinating clinical trials that have the potential to improve the standard of care for many types of cancers,” said Michelle Le Beau, PhD, director of the University of Chicago Medicine Comprehensive Cancer Center.

NRG Oncology requested $68.9 million in federal funding for their effort.

The group is internationally recognized for its special strengths in the conduct of definitive treatment standard-setting trials in cancers including breast, gastrointestinal, prostate, bladder, lung, head and neck, brain and gynecologic sites. It’s also notable for advances in radiation therapy and in undertaking early phase therapy development and groundbreaking translational research in cancer.

NRG Oncology is the largest of five groups that comprise the NCI National Clinical Trials Network (NCTN). Each group has a separate and distinct Operations Center and Statistics and Data Management Center.

The SDMCs are responsible for trial design and development in collaboration with investigators, data management, trial safety and efficacy monitoring, and auditing and quality control, in addition to collaborating on the larger research agenda of the group. SDMCs partner closely with their respective Operations Center, which consists of group leadership for the clinical and scientific research agenda, and is responsible for developing new protocols and managing the regulatory, financial and membership committees as well as the disease site and other scientific committees.

“In addition to continuing to support the critical research mission of NRG, having this leadership role here will provide us the opportunity to grow our clinical trials expertise and presence, which will have many benefits for the Comprehensive Cancer Center and University more broadly,” said James J. Dignam, PhD, Professor of Biostatistics in the Department of Public Health Sciences at the University of Chicago. Dignam will assume the role of Group Statistician and Executive Director of the SDMC for the new six-year grant cycle, which began March 1, 2019.

A team of approximately 80 SDMC members based at the University of Chicago, American College of Radiology, University of Pittsburgh and Roswell Park Cancer Institute will be responsible for all aspects of NRG Oncology multicenter studies that accrue patients from more than 1,800 sites in North America, including the University of Chicago Medicine Comprehensive Cancer Center, and selected participating institutions around the world.

“We look forward to the next six years as we continue to support the clinical trial research effort of NRG Oncology through our work at the SDMC,” Dignam said.

The Comprehensive Cancer Center has long played a role in the NCI’s Cancer Cooperative Groups and its successor program, the National Clinical Trials Network, including as awardees of a Lead Academic Participating Site (LAPS) grant, which is awarded to academic research institutions that have demonstrated their ability to enroll high numbers of patients onto NCTN trials, as well as scientific leadership in the design and conduct of clinical trials.

Comprehensive Cancer Center investigators conduct more than 350 therapeutic clinical trials in cancer, and enroll approximately 1,000 patients each year. Over the past decades and currently, Comprehensive Cancer Center faculty have served in various leadership capacities for cooperative groups and NCTN groups, including NRG Oncology, the Children’s Oncology Group, the Alliance for Clinical Trials in Oncology, the SWOG Cancer Research Network and ECOG-ACRIN Cancer Research Group.

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