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 #
5U10CA180822-03
Application #
9031740
Study Section
Special Emphasis Panel (ZCA1-GRB-I (O1))
Program Officer
Mooney, Margaret M
Project Start
2014-04-18
Project End
2019-02-28
Budget Start
2016-03-01
Budget End
2017-02-28
Support Year
3
Fiscal Year
2016
Total Cost
$10,463,203
Indirect Cost
$1,244,708
Name
University of Pittsburgh
Department
Biostatistics & Other Math Sci
Type
Other Domestic Higher Education
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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 :
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
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
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
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
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
Rebbeck, Timothy R (see original citation for additional authors) (2018) Mutational spectrum in a worldwide study of 29,700 families with BRCA1 or BRCA2 mutations. Hum Mutat 39:593-620
Wapnir, Irene L; Price, Karen N; Anderson, Stewart J et al. (2018) Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol 36:1073-1079
Cosgrove, Casey M; Tritchler, David L; Cohn, David E et al. (2018) An NRG Oncology/GOG study of molecular classification for risk prediction in endometrioid endometrial cancer. Gynecol Oncol 148:174-180
Valicenti, Richard K; Pugh, Stephanie L; Trabulsi, Edouard J et al. (2018) First Report of NRG Oncology/Radiation Therapy Oncology Group 0622: A Phase 2 Trial of Samarium-153 Followed by Salvage Prostatic Fossa Irradiation in High-Risk Clinically Nonmetastatic Prostate Cancer After Radical Prostatectomy. Int J Radiat Oncol Biol Phys 100:695-701

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