The objective of this proposal is to establish and maintain the Statistical and Data Management Center (SDMC) of the NRG Oncology National Clinical Trials Network (NCTN) Group. The SDMC is the result of joining the Legacy SDMCs from three NCI Cancer Cooperative Groups, the NSABP, RTOG and GOG, which together have over 150 years of combined experience operating SDMCs in support of the clinical trial research effort of the National Cancer Institute. The diverse background of the integrated SDMC is integral to NRG Oncology's ability to execute a research portfolio that spans a broad spectrum of diseases. It has a unique concentration in gender-specific malignancies: breast cancer, gynecologic cancer, prostate cancer, and advanced radiation therapy technology, as well as a leading presence in several other cancers. The successful integration of this breadth of experience and expertise establishes a span of clinical research that does not exist in any other NCTN research entity. The SDMC will ensure that scientifically relevant research in these areas is developed, conducted with state-of-the-art methodology, and interpreted and presented to maximize impact on evidence-based medicine. With its organizational structure, disease expertise, noteworthy experience, and focused dedication, this collaborative SDMC is uniquely positioned to achieve its goals including but not limited to; harmonize the diverse knowledge, experience, and resources of the Legacy SDMCs to create a unique NRG Oncology SDMC that transcends the established excellence of its individual components; participate fully in leadership and the determination of the Group's scientific direction; oversee/participate in NRG Oncology translational research, clinical trial activities and correlative studies; provide efficiet, methodologically up-to-date trial design, monitoring, reporting, and analysis; provide comprehensive data management/quality control to ensure high quality and timely data for analysis; leverage cutting edge information technology (IT) emphasizing data integrity, security, timeliness, and efficiency of data collection and management; provide education and training for institutional Clinical Research Associates, Study Chairs, and others involved in the NRG Oncology research agenda; provide IT advice and collaborative support for technologic activities bf NRG Oncology, such as website design and maintenance, facilitation of mass communication with membership, and similar functions; and oversee implementation, conduct, and evaluation of the NRG Oncology Quality Assurance Audit Program. Finally, the proven ability of all SDMC Divisions to collaborate successfully with one another, as well as with NRG Oncology, is a cornerstone upon which cutting edge science will be built.

Public Health Relevance

Morbidity and mortality from cancer is a significant public health problem. There is a tremendous need to identify more effective and cost efficient modalities for the treatment of cancer, while also improving the quality of life and well-being for cancer patients. The SDMC is an integral component of the NRG Oncology NCTN Group, and is critical to ensuring that scientifically sound and relevant research in cancer is properly designed, implemented, analyzed, interpreted, and disseminated.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA180822-05
Application #
9442707
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Mooney, Margaret M
Project Start
2014-04-18
Project End
2019-02-28
Budget Start
2018-03-01
Budget End
2019-02-28
Support Year
5
Fiscal Year
2018
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Cook, Elise D; Yeager, Katherine A; Cecchini, Reena S et al. (2018) Recruitment practices for U.S. minority and underserved populations in NRG oncology: Results of an online survey. Contemp Clin Trials Commun 10:100-104
Chan, John K; Brady, William; Monk, Bradley J et al. (2018) A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma: An NRG Oncology/Gynecologic Oncology Group Study (GOG-254). Gynecol Oncol 150:247-252
Klopp, Ann H; Yeung, Anamaria R; Deshmukh, Snehal et al. (2018) Patient-Reported Toxicity During Pelvic Intensity-Modulated Radiation Therapy: NRG Oncology-RTOG 1203. J Clin Oncol 36:2538-2544
Eskander, Ramez N; Kauderer, James; Tewari, Krishnansu S et al. (2018) Correlation between Surgeon's assessment and radiographic evaluation of residual disease in women with advanced stage ovarian cancer reported to have undergone optimal surgical cytoreduction: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol 149:525-530
Timmerman, Robert D; Hu, Chen; Michalski, Jeff M et al. (2018) Long-term Results of Stereotactic Body Radiation Therapy in Medically Inoperable Stage I Non-Small Cell Lung Cancer. JAMA Oncol 4:1287-1288
Matulonis, Ursula A; Sill, Michael W; Makker, Vicky et al. (2018) A randomized phase II study of cabozantinib versus weekly paclitaxel in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol :
Horowitz, Neil S; Larry Maxwell, G; Miller, Austin et al. (2018) Predictive modeling for determination of microscopic residual disease at primary cytoreduction: An NRG Oncology/Gynecologic Oncology Group 182 Study. Gynecol Oncol 148:49-55
Boardman, Cecelia H; Brady, William E; Dizon, Don S et al. (2018) A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cervical Carcinoma Metastatic to the Para-aortic Lymph Nodes: An NRG Oncology/Gynecologic On Gynecol Oncol 151:202-207
Michalski, Jeff M; Moughan, Jennifer; Purdy, James et al. (2018) Effect of Standard vs Dose-Escalated Radiation Therapy for Patients With Intermediate-Risk Prostate Cancer: The NRG Oncology RTOG 0126 Randomized Clinical Trial. JAMA Oncol 4:e180039
Hu, Chen; Steingrimsson, Jon Arni (2018) Personalized Risk Prediction in Clinical Oncology Research: Applications and Practical Issues Using Survival Trees and Random Forests. J Biopharm Stat 28:333-349

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