The Alliance for Clinical Trials in Oncology (Alliance) was formed on July 15, 2011 through the merger of 3 legacy groups: The Cancer and Leukemia Group B (CALGB), the North Central Cancer Treatment Group (NCCTG) and the American College of Surgeons Oncology Group (ACOSOG). The Alliance Statistics and Data Center (SDC) is responsible for all statistical and data management needs for the Alliance. Under the leadership of Dr. Sargent as the Alliance Group Statistician, in the brief span since the merger, the Alliance SDC has been and now is a completely integrated, single, comprehensive center with a clear, experienced leadership structure including legacy leaders from the ACOSOG, CALGB, and NCCTG SDCs. This has been accomplished while retaining 15 of 16 legacy senior statistical faculty, implementing Medidata Rave for all new Alliance clinical trials, consolidating to a single information systems infrastructure, meeting all NCI Operational Efficiency Working Group timelines, and opening 6 clinical trials from investigators external to the Alliance. From January 1, 2007 - August 1, 2012, the Alliance SDC provided statistical, data management, and IT collaboration and support for 99 Alliance treatment clinical trials that opened to accrual, 236 trials opened prior to that period for which patient follow-up was continuing, and published 296 manuscripts reporting on Alliance led clinical trials, associated correlative, or retrospective studies. The accomplishments described throughout this application demonstrate that the SDC has rapidly and effectively achieved integration of all legacy group activities and is actively pursuing a unified strategy for future Alliance science. The Alliance SDC has kept pace with and in many cases led innovation in the scientific, administrative, and technological arenas of cancer research, and is ideally poised to meet the challenges of cancer clinical trials in 2014 and beyond. Alliance faculty includes methodological leaders in biomarker-based clinical trial design, adaptive trials, bioinformatics, and early stage clinical trial design. SDC clinical data systems ae fully integrated with Alliance laboratories to allow real-time integration of biomarkers into trial as well as to facilitate external access to Alliance clinical and biologic data. Alliance systems ae robust and scalable, with demonstrated ability to dynamically collaborate with: 1) international efforts (e.g., N1048, Cio6o3, A091104), 2) trials initiated from investigators completely external to the Alliance (e.g., A091101, A91104), 3) rare tumor trials (e.g., A091102, A091105), and to expand to new collaborations as necessary. The Alliance SDC is a full partner in all relevant NCI/NCTN activities, and is committed to continuing its collaborative leadership role in the new NCTN program.

Public Health Relevance

The Alliance Statistics and Data Center is responsible for the statistical, data management, and information technology activities that support the scientific agenda of the Alliance for Clinical Trials in Oncology, a national cancer research organization. Successful execution of these activities leads to the translation of basic and clinical research into trials of new therapies that have the potential to change clinical practice, resulting in improved outcomes for cancer patients world-wide.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZCA1-GRB-I (O1))
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Mooney, Margaret M
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Mayo Clinic, Rochester
United States
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Walker, Christopher J; Oakes, Christopher C; Genutis, Luke K et al. (2018) Genome-wide association study identifies an acute myeloid leukemia susceptibility locus near BICRA. Leukemia :
Byrd, John C; Ruppert, Amy S; Heerema, Nyla A et al. (2018) Lenalidomide consolidation benefits patients with CLL receiving chemoimmunotherapy: results for CALGB 10404 (Alliance). Blood Adv 2:1705-1718
Choueiri, Toni K; Hessel, Colin; Halabi, Susan et al. (2018) Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update. Eur J Cancer 94:115-125
Vasu, Sumithira; Kohlschmidt, Jessica; Mrózek, Krzysztof et al. (2018) Ten-year outcome of patients with acute myeloid leukemia not treated with allogeneic transplantation in first complete remission. Blood Adv 2:1645-1650
D'Angelo, Sandra P; Mahoney, Michelle R; Van Tine, Brian A et al. (2018) Nivolumab with or without ipilimumab treatment for metastatic sarcoma (Alliance A091401): two open-label, non-comparative, randomised, phase 2 trials. Lancet Oncol 19:416-426
Phipps, Amanda I; Shi, Qian; Zemla, Tyler J et al. (2018) Physical Activity and Outcomes in Patients with Stage III Colon Cancer: A Correlative Analysis of Phase III Trial NCCTG N0147 (Alliance). Cancer Epidemiol Biomarkers Prev 27:696-703
Chumsri, Saranya; Sperinde, Jeff; Liu, Heshan et al. (2018) High p95HER2/HER2 Ratio Associated With Poor Outcome in Trastuzumab-Treated HER2-Positive Metastatic Breast Cancer NCCTG N0337 and NCCTG 98-32-52 (Alliance). Clin Cancer Res 24:3053-3058
Urbanic, James J; Wang, Xiaofei; Bogart, Jeffrey A et al. (2018) Phase 1 Study of Accelerated Hypofractionated Radiation Therapy With Concurrent Chemotherapy for Stage III Non-Small Cell Lung Cancer: CALGB 31102 (Alliance). Int J Radiat Oncol Biol Phys 101:177-185
Gajra, Ajeet; McCall, Linda; Muss, Hyman B et al. (2018) The preference to receive chemotherapy and cancer-related outcomes in older adults with breast cancer CALGB 49907 (Alliance). J Geriatr Oncol 9:221-227
Innocenti, Federico; Jiang, Chen; Sibley, Alexander B et al. (2018) Genetic variation determines VEGF-A plasma levels in cancer patients. Sci Rep 8:16332

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