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)
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Mooney, Margaret M
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Mayo Clinic, Rochester
United States
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Mehrotra, Shailly; Sharma, Manish R; Gray, Elizabeth et al. (2017) Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance). AAPS J 19:1411-1423
Smith, Sonali M; Pitcher, Brandelyn N; Jung, Sin-Ho et al. (2017) Safety and tolerability of idelalisib, lenalidomide, and rituximab in relapsed and refractory lymphoma: the Alliance for Clinical Trials in Oncology A051201 and A051202 phase 1 trials. Lancet Haematol 4:e176-e182
Boughey, Judy C; Ballman, Karla V; McCall, Linda M et al. (2017) Tumor Biology and Response to Chemotherapy Impact Breast Cancer-specific Survival in Node-positive Breast Cancer Patients Treated With Neoadjuvant Chemotherapy: Long-term Follow-up From ACOSOG Z1071 (Alliance). Ann Surg 266:667-676
Niedzwiecki, Donna; Hasson, Rian M; Lenz, Heinz-Josef et al. (2017) A Study of Thymidylate Synthase Expression as a Biomarker for Resectable Colon Cancer: Alliance (Cancer and Leukemia Group B) 9581 and 89803. Oncologist 22:107-114
Venook, Alan P; Niedzwiecki, Donna; Lenz, Heinz-Josef et al. (2017) Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA 317:2392-2401
Papaioannou, Dimitrios; Nicolet, Deedra; Volinia, Stefano et al. (2017) Prognostic and biologic significance of long non-coding RNA profiling in younger adults with cytogenetically normal acute myeloid leukemia. Haematologica 102:1391-1400
Hubbard, Joleen M; Mahoney, Michelle R; Loui, William S et al. (2017) Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma: North Central Cancer Treatment Group Trial N0745 (Alliance). Target Oncol 12:201-209
Ligibel, Jennifer A; Barry, William T; Alfano, Catherine et al. (2017) Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design. NPJ Breast Cancer 3:37
Brown, Paul D; Ballman, Karla V; Cerhan, Jane H et al. (2017) Postoperative stereotactic radiosurgery compared with whole brain radiotherapy for resected metastatic brain disease (NCCTG N107C/CECĀ·3): a multicentre, randomised, controlled, phase 3 trial. Lancet Oncol 18:1049-1060
Katz, Matthew H G; Ou, Fang-Shu; Herman, Joseph M et al. (2017) Alliance for clinical trials in oncology (ALLIANCE) trial A021501: preoperative extended chemotherapy vs. chemotherapy plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the head of the pancreas. BMC Cancer 17:505

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