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 Administrative Core provides the components of the SDMC critical to a) leadership within the SDMC overall and between Core components, b) coordination with NRG Oncology Operations to effectively provide to the group necessary support for the research agenda and for investigators, including vital functions such as data and trial quality assurance and c) coordination with other Network groups and with the NCI to collectively meet the goals of the NCTN. The 2019-2024 cycle represents the second period of the NCTN program, which succeeded the NCI Cancer Cooperative Group program, of which NRG Oncology was formed by the unification of three existing Cooperative Groups. The re-organization to provide a structure that capitalizes on a wealth of skills and experience while avoiding inefficiencies was a challenge successfully met in the first cycle. The current leadership structure provides seamless work among sites under common procedures, with divisions organized by function rather than geography, while continuing to take advantage of longstanding expertise that may reside in a specific office (and thus are not redundant). Success during the first cycle is evidence by over 45 new trials either initiated or currently approved and in development, while accrual and/or follow-up to primary and secondary endpoint reporting on over 80 additional trials that were active at the inception of NRG Oncology. The NRG Oncology trials accruing during 2014-2017 represent 34% of all accruing NCTN trials. Publications from the group in the first cycle number well over 300, including 39 methodology articles by SDMC statisticians. The administrative structure of the SDMC has allowed it to serve as a highly functioning productive resource for NRG Oncology and the NCTN. In the second cycle of the NCTN, the Administrative Core will continue to enhance the integration of the group towards a seamless unit that serves all the operational needs of the SDMC as it carries out its mission. Specifically, the Administrative Core will provide the governance, strategic planning, scientific direction, logistical oversight, administrative resources and decision-making for the NRG Oncology Statistics and Data Management Center. The Core will lead critical liaisons with the NRG Operations Center, NCTN member groups, the NCI, pharmaceutical companies, and the FDA to ensure that research goals are met. The Core will provide quality assurance oversight to the other SDMC sections and to the NRG investigative sites, ensuring the integrity of the database and trial findings. Finally, the core will provide administrative resources and training to SDMC staff through adherence to its library of Standard Operating Procedures (SOPs).!
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