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)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZCA1)
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Mooney, Margaret M
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Mayo Clinic, Rochester
United States
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Park, Haeseong; Qin, Rui; Smith, Thomas J et al. (2015) North Central Cancer Treatment Group N10C2 (Alliance): a double-blind placebo-controlled study of magnesium supplements to reduce menopausal hot flashes. Menopause 22:627-32
Lilenbaum, Rogerio; Samuels, Michael; Wang, Xiaofei et al. (2015) A phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poor-risk stage III non-small-cell lung cancer: results of CALGB 30605 (Alliance)/RTOG 0972 (NRG). J Thorac Oncol 10:143-7
Niederwieser, C; Kohlschmidt, J; Volinia, S et al. (2015) Prognostic and biologic significance of DNMT3B expression in older patients with cytogenetically normal primary acute myeloid leukemia. Leukemia 29:567-75
Rizzieri, David A; Johnson, Jeffrey L; Byrd, John C et al. (2014) Improved efficacy using rituximab and brief duration, high intensity chemotherapy with filgrastim support for Burkitt or aggressive lymphomas: cancer and Leukemia Group B study 10 002. Br J Haematol 165:102-11
Beumer, Jan H; Owzar, Kouros; Lewis, Lionel D et al. (2014) Effect of age on the pharmacokinetics of busulfan in patients undergoing hematopoietic cell transplantation; an alliance study (CALGB 10503, 19808, and 100103). Cancer Chemother Pharmacol 74:927-38
Kolitz, Jonathan E; George, Stephen L; Benson Jr, Don M et al. (2014) Recombinant interleukin-2 in patients aged younger than 60 years with acute myeloid leukemia in first complete remission: results from Cancer and Leukemia Group B 19808. Cancer 120:1010-7
Boughey, Judy C; McCall, Linda M; Ballman, Karla V et al. (2014) Tumor biology correlates with rates of breast-conserving surgery and pathologic complete response after neoadjuvant chemotherapy for breast cancer: findings from the ACOSOG Z1071 (Alliance) Prospective Multicenter Clinical Trial. Ann Surg 260:608-14; discussion 614-6
Whitman, S P; Kohlschmidt, J; Maharry, K et al. (2014) GAS6 expression identifies high-risk adult AML patients: potential implications for therapy. Leukemia 28:1252-8