NRG Oncology - Statistical and Data Management Center

Abstract The mission of the NRG Oncology Statistics and Data Management Center (SDMC) is to provide all necessary expertise and personnel for the design, conduct and analysis of clinical trials and associated research for NRG Oncology, a member group of the NCI National Clinical Trials Network (NCTN) program. The 2019-2024 cycle represents the second period of the NCTN program, which succeeded the NCI Cancer Cooperative Group program and of which NRG Oncology was formed by the unification of three of the Cooperative Groups. NRG Oncology has unique expertise in gender-specific malignancies (breast, gynecologic, and prostate cancer), as well as a major presence in several other cancer types (head & neck, lung, brain, upper GI) where multimodality therapy has a critical role. In the first cycle of the NCTN (2014-2019), the NRG SDMC and partner NRG Operations Center personnel expended significant effort in successfully transforming into a truly united and highly functioning group. Concurrently, the group made significant strides in advancing cancer treatment, ancillary care, and cancer biologic knowledge. During the first cycle, the group initiated 32 trials and obtained final approval on an additional 14 trials for development, while maintaining follow-up to primary and secondary endpoint reporting on over 80 additional trials that were active at the inception of NRG Oncology. Publications from the group through the initial 5 years number over 300, including 39 methodology articles by SDMC statisticians. To carry out its mission, the NRG Oncology SDMC will collaborate closely with NRG Oncology Operations leadership and trial investigators to design and conduct the highest quality clinical trials that will yield definitive conclusions. The SDMC will provide continuous trial conduct oversight through all stages from concept inception through protocol development, trial activation, trial monitoring, and dissemination of findings. Through its quality assurance program, the SDMC will provide quality control monitoring across the lifecycle of trials. The SDMC will continue to apply, or develop as needed, innovative statistical designs in all phases of clinical trials, using integrated developmental trial phases where advantageous, and incorporating biomarker-based information into trial designs and analysis plans. The SDMC will continue to Implement state-of-the-art data management and information technology systems to assure secure high-quality data collection, maintenance, and curation for additional discovery and data sharing with the larger research community.