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.
|Olawaiye, Alexander B; Java, James J; Krivak, Thomas C et al. (2018) Does adjuvant chemotherapy dose modification have an impact on the outcome of patients diagnosed with advanced stage ovarian cancer? An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol 151:18-23|
|Hensley, Martee L; Enserro, Danielle; Hatcher, Helen et al. (2018) Adjuvant Gemcitabine Plus Docetaxel Followed by Doxorubicin Versus Observation for High-Grade Uterine Leiomyosarcoma: A Phase III NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol :JCO1800454|
|Sparano, Joseph A; Gray, Robert J; Makower, Della F et al. (2018) Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med 379:111-121|
|Shi, Wenyin; Scannell Bryan, Molly; Gilbert, Mark R et al. (2018) Investigating the Effect of Reirradiation or Systemic Therapy in Patients With Glioblastoma After Tumor Progression: A Secondary Analysis of NRG Oncology/Radiation Therapy Oncology Group Trial 0525. Int J Radiat Oncol Biol Phys 100:38-44|
|Boxerman, Jerrold L; Zhang, Zheng; Safriel, Yair et al. (2018) Prognostic value of contrast enhancement and FLAIR for survival in newly diagnosed glioblastoma treated with and without bevacizumab: results from ACRIN 6686. Neuro Oncol 20:1400-1410|
|Chinnaiyan, Prakash; Won, Minhee; Wen, Patrick Y et al. (2018) A randomized phase II study of everolimus in combination with chemoradiation in newly diagnosed glioblastoma: results of NRG Oncology RTOG 0913. Neuro Oncol 20:666-673|
|Hamilton, C A; Miller, A; Casablanca, Y et al. (2018) Clinicopathologic characteristics associated with long-term survival in advanced epithelial ovarian cancer: an NRG Oncology/Gynecologic Oncology Group ancillary data study. Gynecol Oncol 148:275-280|
|Small Jr, William; James, Jennifer L; Moore, Timothy D et al. (2018) Utility of the ACE Inhibitor Captopril in Mitigating Radiation-associated Pulmonary Toxicity in Lung Cancer: Results From NRG Oncology RTOG 0123. Am J Clin Oncol 41:396-401|
|Younge, Kelly C; Marsh, Robin B; Owen, Dawn et al. (2018) Improving Quality and Consistency in NRG Oncology Radiation Therapy Oncology Group 0631 for Spine Radiosurgery via Knowledge-Based Planning. Int J Radiat Oncol Biol Phys 100:1067-1074|
|Lukka, Himanshu R; Pugh, Stephanie L; Bruner, Deborah W et al. (2018) Patient Reported Outcomes in NRG Oncology RTOG 0938, Evaluating Two Ultrahypofractionated Regimens for Prostate Cancer. Int J Radiat Oncol Biol Phys 102:287-295|
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