# NRG Oncology - Statistical and Data Management Center

> **NIH NIH U10** · UNIVERSITY OF CHICAGO · 2022 · $9,974,677

## 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 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 large...

## Key facts

- **NIH application ID:** 10359752
- **Project number:** 5U10CA180822-09
- **Recipient organization:** UNIVERSITY OF CHICAGO
- **Principal Investigator:** James J. Dignam
- **Activity code:** U10 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $9,974,677
- **Award type:** 5
- **Project period:** 2014-04-18 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10359752

## Citation

> US National Institutes of Health, RePORTER application 10359752, NRG Oncology - Statistical and Data Management Center (5U10CA180822-09). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10359752. Licensed CC0.

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