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 Data Management Core of the SDMC provides the expertise to develop software, data collection mechanisms, database storage, and data management processes for state of the art clinical conduct, and to implement these tools and methods to manage the NRG Oncology clinical trial portfolio. 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. During the first cycle of the NCTN, the NRG Oncology SDMC has expended significant effort harmonizing data management and information technology practices in order to successfully transform into a united entity operating under common procedures and using the Medidata Rave database system. While maintaining a geographically distributed model, the Data Management Core now operates as a single highly efficient and productive unit, as evidenced by the successful initiation of 32 new trials and final approval on an additional 14 trials now in development, while continuing to maintain 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. Publications from the group in the first cycle number well over 300. In this second NCTN cycle, the Data Management Core will build on early success and continue to deliver comprehensive support for NRG Oncology clinical trials and related research, as well as support the additional information technology needs of the NRG Operations Center. Specifically, the Core will coordinate all study design and process decisions in collaboration with personnel from Data Management, Quality Assurance, Statistics, Information Technology, Protocol Development, and Imaging Technology. The Core will continue to advance the use of Rave functionality, including edit checks, query management, study calendar implementation, automated email alerts, import of imaging data, and reporting functions. The Core will conduct systems analysis of protocol data collection, review, and reporting requirements, extending Rave intrinsic functionality through custom programming, and develop additional data management tools for the web environment. The Core will provide comprehensive data quality control to assure data timeliness, accuracy, and validity. Finally, in information technology, the Core will continue to provide systems analysis, project management, and software development to support data management, statistical, and reporting needs for both the SDMC and the NRG Oncology Operations Office, and participate in NCTN working groups to support NCTN initiatives through systems analysis, code sharing, and the expansion of web services.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10CA180822-06
Application #
9628264
Study Section
Special Emphasis Panel (ZCA1)
Project Start
Project End
Budget Start
2019-03-28
Budget End
2020-02-29
Support Year
6
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of Chicago
Department
Type
DUNS #
005421136
City
Chicago
State
IL
Country
United States
Zip Code
60637
Hensley, Martee L; Enserro, Danielle; Hatcher, Helen et al. (2018) Adjuvant Gemcitabine Plus Docetaxel Followed by Doxorubicin Versus Observation for High-Grade Uterine Leiomyosarcoma: A Phase III NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol :JCO1800454
Olawaiye, Alexander B; Java, James J; Krivak, Thomas C et al. (2018) Does adjuvant chemotherapy dose modification have an impact on the outcome of patients diagnosed with advanced stage ovarian cancer? An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol 151:18-23
Shi, Wenyin; Scannell Bryan, Molly; Gilbert, Mark R et al. (2018) Investigating the Effect of Reirradiation or Systemic Therapy in Patients With Glioblastoma After Tumor Progression: A Secondary Analysis of NRG Oncology/Radiation Therapy Oncology Group Trial 0525. Int J Radiat Oncol Biol Phys 100:38-44
Sparano, Joseph A; Gray, Robert J; Makower, Della F et al. (2018) Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med 379:111-121
Chinnaiyan, Prakash; Won, Minhee; Wen, Patrick Y et al. (2018) A randomized phase II study of everolimus in combination with chemoradiation in newly diagnosed glioblastoma: results of NRG Oncology RTOG 0913. Neuro Oncol 20:666-673
Boxerman, Jerrold L; Zhang, Zheng; Safriel, Yair et al. (2018) Prognostic value of contrast enhancement and FLAIR for survival in newly diagnosed glioblastoma treated with and without bevacizumab: results from ACRIN 6686. Neuro Oncol 20:1400-1410
Small Jr, William; James, Jennifer L; Moore, Timothy D et al. (2018) Utility of the ACE Inhibitor Captopril in Mitigating Radiation-associated Pulmonary Toxicity in Lung Cancer: Results From NRG Oncology RTOG 0123. Am J Clin Oncol 41:396-401
Hamilton, C A; Miller, A; Casablanca, Y et al. (2018) Clinicopathologic characteristics associated with long-term survival in advanced epithelial ovarian cancer: an NRG Oncology/Gynecologic Oncology Group ancillary data study. Gynecol Oncol 148:275-280
Lukka, Himanshu R; Pugh, Stephanie L; Bruner, Deborah W et al. (2018) Patient Reported Outcomes in NRG Oncology RTOG 0938, Evaluating Two Ultrahypofractionated Regimens for Prostate Cancer. Int J Radiat Oncol Biol Phys 102:287-295
Younge, Kelly C; Marsh, Robin B; Owen, Dawn et al. (2018) Improving Quality and Consistency in NRG Oncology Radiation Therapy Oncology Group 0631 for Spine Radiosurgery via Knowledge-Based Planning. Int J Radiat Oncol Biol Phys 100:1067-1074

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