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.
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.
|Truong, Minh Tam; Zhang, Qiang; Rosenthal, David I et al. (2017) Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Accelerated Radiation Plus Cisplatin With or Without Cetuximab for Locally Advanced Head and Neck Carcinoma: NRG Oncology Radiatio Int J Radiat Oncol Biol Phys 97:687-699|
|Gore, Elizabeth M; Hu, Chen; Sun, Alexander Y et al. (2017) Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extracranial Irradiation for Extensive-Disease Small Cell Lung Cancer (ED SCLC): NRG Oncology RTOG 0937. J Thorac Oncol 12:1561-1570|
|Mirhadi, Amin J; Zhang, Qiang; Hanks, Gerald E et al. (2017) Effect of Long-Term Hormonal Therapy (vs Short-Term Hormonal Therapy): A Secondary Analysis of Intermediate-Risk Prostate Cancer Patients Treated on NRG Oncology RTOG 9202. Int J Radiat Oncol Biol Phys 97:511-515|
|Holdhoff, Matthias; Cairncross, Gregory J; Kollmeyer, Thomas M et al. (2017) Genetic landscape of extreme responders with anaplastic oligodendroglioma. Oncotarget 8:35523-35531|
|Phippen, N T; Secord, A A; Wolf, S et al. (2017) Quality of life is significantly associated with survival in women with advanced epithelial ovarian cancer: An ancillary data analysis of the NRG Oncology/Gynecologic Oncology Group (GOG-0218) study. Gynecol Oncol 147:98-103|
|Gavin, Patrick G; Song, Nan; Kim, S Rim et al. (2017) Association of Polymorphisms in FCGR2A and FCGR3A With Degree of Trastuzumab Benefit in the Adjuvant Treatment of ERBB2/HER2-Positive Breast Cancer: Analysis of the NSABP B-31 Trial. JAMA Oncol 3:335-341|
|Hagar, Yolanda; Dignam, James J; Dukic, Vanja (2017) Flexible modeling of the hazard rate and treatment effects in long-term survival studies. Stat Methods Med Res 26:2455-2480|
|Tewari, Krishnansu S; Sill, Michael W; Penson, Richard T et al. (2017) Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). Lancet 390:1654-1663|
|Ying, Gui-Shuang; Zhang, Qiang; Lan, Yu et al. (2017) Cure modeling in real-time prediction: How much does it help? Contemp Clin Trials 59:30-37|
|Cohn, David E; Sill, Michael W; Walker, Joan L et al. (2017) Randomized phase IIB evaluation of weekly paclitaxel versus weekly paclitaxel with oncolytic reovirus (Reolysin®) in recurrent ovarian, tubal, or peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol 146:477-483|
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