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 cancer types (head & neck, lung, brain, upper GI) where radiotherapy has a critical role in conjunction with other modalities. In the first cycle (2014-2019) of the NCTN, the NRG Oncology SDMC and partner Operations Center personnel expended significant effort in successfully transforming into a truly united and highly functioning group. Success in this effort for the SDMC is evident throughout the renewal application. At the same time, the new group made significant strides in advancing cancer treatment, ancillary care, and biologic knowledge, which is also thoroughly in evidence through the clinical/scientific output of NRG Oncology, and through contributions of the SDMC to clinical trials methodology and practice. During the first cycle, the group initiated 32 new trials and obtained final approval on an additional 14 trials that are now in development, while maintaining 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 to date number over 300, including 39 methodology articles by SDMC statisticians. In the second NCTN period, NRG Oncology anticipates even greater success, and the SDMC is critical to achieving this goal. To carry out its mission, the NRG Oncology SDMC will continue to collaborate closely with NRG Oncology leadership and trial investigators to design and conduct 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 monitoring, initial reporting, and publication. Through its quality assurance program, the SDMC will provide quality control checks 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 phases of trials where advantageous, and incorporating modern biomarker based information into trial designs and their attendant 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.

Public Health Relevance

While outcomes have been improved for many cancers, there remains a substantial need to develop and validate more effective treatments, while also improving the quality of life and well-being for cancer patients. The NRG Oncology National Clinical Trials Network (NCTN) group addresses this need, and the NRG Oncology Statistics and Data Management Center (SDMC) represents an integral component critical to ensuring that NRG Oncology clinical trials are properly designed, implemented, conducted, analyzed, and disseminated. This application seeks resources for the NRG Oncology SDMC to support the NRG Oncology and NCTN research agenda for the 2019-2024 program period. !

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA180822-08
Application #
10165552
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Mooney, Margaret M
Project Start
2014-04-18
Project End
2025-02-28
Budget Start
2021-03-01
Budget End
2022-02-28
Support Year
8
Fiscal Year
2021
Total Cost
Indirect Cost
Name
University of Chicago
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
005421136
City
Chicago
State
IL
Country
United States
Zip Code
60637
Cho, Youngjoo; Hu, Chen; Ghosh, Debashis (2018) Covariate adjustment using propensity scores for dependent censoring problems in the accelerated failure time model. Stat Med 37:390-404
Ali, Arif N; Zhang, Peixin; Yung, W K Alfred et al. (2018) NRG oncology RTOG 9006: a phase III randomized trial of hyperfractionated radiotherapy (RT) and BCNU versus standard RT and BCNU for malignant glioma patients. J Neurooncol 137:39-47
Roach, Mack; Moughan, Jennifer; Lawton, Colleen A F et al. (2018) Sequence of hormonal therapy and radiotherapy field size in unfavourable, localised prostate cancer (NRG/RTOG 9413): long-term results of a randomised, phase 3 trial. Lancet Oncol 19:1504-1515
Dignam, James J; Hamstra, Daniel A; Lepor, Herbert et al. (2018) Time Interval to Biochemical Failure as a Surrogate End Point in Locally Advanced Prostate Cancer: Analysis of Randomized Trial NRG/RTOG 9202. J Clin Oncol :JCO1800154
Basch, Ethan; Dueck, Amylou C; Rogak, Lauren J et al. (2018) Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048. J Clin Oncol :JCO2018788620
Videtic, Gregory M; Paulus, Rebecca; Singh, Anurag K et al. (2018) Long term follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A randomized phase II study comparing 2 stereotactic body radiation therapy schedules for medically inoperable patients with stage I peripheral non-small cell lung cancer. Int J Radiat Oncol Biol Phys :
Timmerman, Robert D; Paulus, Rebecca; Pass, Harvey I et al. (2018) Stereotactic Body Radiation Therapy for Operable Early-Stage Lung Cancer: Findings From the NRG Oncology RTOG 0618 Trial. JAMA Oncol 4:1263-1266
Tew, William P; Sill, Michael W; Walker, Joan L et al. (2018) Randomized phase II trial of bevacizumab plus everolimus versus bevacizumab alone for recurrent or persistent ovarian, fallopian tube or peritoneal carcinoma: An NRG oncology/gynecologic oncology group study. Gynecol Oncol 151:257-263
Regine, William F; Winter, Kathryn; Abrams, Ross A et al. (2018) Postresection CA19-9 and margin status as predictors of recurrence after adjuvant treatment for pancreatic carcinoma: Analysis of NRG oncology RTOG trial 9704. Adv Radiat Oncol 3:154-162
Richardson, Debra L; Sill, Michael W; Coleman, Robert L et al. (2018) Paclitaxel With and Without Pazopanib for Persistent or Recurrent Ovarian Cancer: A Randomized Clinical Trial. JAMA Oncol 4:196-202

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