Alliance Statistics and Data Management Center PROJECT SUMMARY The Alliance for Clinical Trials in Oncology (Alliance) was founded on July 15, 2011, through the merger of 3 legacy groups: Cancer and Leukemia Group B, North Central Cancer Treatment Group, and American College of Surgeons Oncology Group. The Alliance Statistics and Data Management Center (SDMC) is responsible for all statistics, data management, and Information Technology functions for the Alliance and, as such, is an integral part of the Alliance's mission. Despite being formed from 3 distinctive groups, all SDMC activities are now consolidated at a single location at the Mayo Clinic under the leadership of Dr. Sumithra Mandrekar as the Alliance Group Statistician, all while undergoing a leadership transition due to the untimely death of the previous group statistician, Dr. Daniel Sargent. Alliance faculty includes methodological leaders in biomarker-based clinical trial design, adaptive trials, surrogate endpoint evaluations, development of methodology and computing tools for identification of predictive genomic markers, and early-stage clinical trial design. From March 1, 2014 ? August 31, 2017, the SDMC provided statistical, data management, and IT collaboration for 20 treatment trials currently in development, 21 treatment trials that opened to accrual and, 100 trials that opened prior to March 2014, for which patient follow-up or manuscript preparation is in progress. SDMC members were authors on 234 published manuscripts reporting on Alliance- led clinical trials and associated correlative or retrospective studies, authored an additional 149 reviews, editorials, or position papers on novel statistical and bioinformatics methods, analyses and software, and provided substantial statistical support and leadership on 44 publications which leverage individual patient data from multiple Alliance studies. SDMC systems are robust and scalable and support all needs of the Alliance. The SDMC has implemented Medidata Rave for all trials, consolidated to a single information systems infrastructure, met all NCI OEWG timelines, collaborated on international trials, partnered on prospective and retrospective registration trials, and is leading the ALCHEMIST trial, A151216 (part of the NCI precision medicine initiative). The SDMC has contributed to several national NCTN systems initiatives: piloting of the ePRO system, Source Data Verification, integrations between Rave and CTEP- AERs, implementing the Data Quality Portal and Central Monitoring Portal, and partnering on the NCTN Biospecimen Navigator. The Alliance SDMC has kept pace with, and in many cases led, innovation in scientific, administrative, and technological arenas of cancer research, and is ideally poised to meet the challenges of cancer clinical trials in 2018 and beyond.

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Alliance Statistics and Data Management Center PROJECT NARRATIVE The Alliance Statistics and Data Management 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 had led to and will continue to lead 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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Eisfeld, Ann-Kathrin; Kohlschmidt, Jessica; Mrózek, Krzysztof et al. (2018) Mutation patterns identify adult patients with de novo acute myeloid leukemia aged 60 years or older who respond favorably to standard chemotherapy: an analysis of Alliance studies. Leukemia 32:1338-1348
McCleary, Nadine J; Hubbard, Joleen; Mahoney, Michelle R et al. (2018) Challenges of conducting a prospective clinical trial for older patients: Lessons learned from NCCTG N0949 (alliance). J Geriatr Oncol 9:24-31
Le-Petross, Huong T; McCall, Linda M; Hunt, Kelly K et al. (2018) Axillary Ultrasound Identifies Residual Nodal Disease After Chemotherapy: Results From the American College of Surgeons Oncology Group Z1071 Trial (Alliance). AJR Am J Roentgenol 210:669-676
Woyach, Jennifer A; Ruppert, Amy S; Heerema, Nyla A et al. (2018) Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL. N Engl J Med 379:2517-2528
Brown, Justin C; Zhang, Sui; Niedzwiecki, Donna et al. (2018) Grain Intake and Clinical Outcome in Stage III Colon Cancer: Results From CALGB 89803 (Alliance). JNCI Cancer Spectr 2:pky017
Gounder, Mrinal M; Mahoney, Michelle R; Van Tine, Brian A et al. (2018) Sorafenib for Advanced and Refractory Desmoid Tumors. N Engl J Med 379:2417-2428
Eisfeld, Ann-Kathrin; Kohlschmidt, Jessica; Mrózek, Krzysztof et al. (2018) NF1 mutations are recurrent in adult acute myeloid leukemia and confer poor outcome. Leukemia 32:2536-2545
Fadelu, Temidayo; Zhang, Sui; Niedzwiecki, Donna et al. (2018) Nut Consumption and Survival in Patients With Stage III Colon Cancer: Results From CALGB 89803 (Alliance). J Clin Oncol 36:1112-1120
Van Blarigan, Erin L; Fuchs, Charles S; Niedzwiecki, Donna et al. (2018) Association of Survival With Adherence to the American Cancer Society Nutrition and Physical Activity Guidelines for Cancer Survivors After Colon Cancer Diagnosis: The CALGB 89803/Alliance Trial. JAMA Oncol 4:783-790
Rosenkranz, Kari M; Ballman, Karla; McCall, Linda et al. (2018) The Feasibility of Breast-Conserving Surgery for Multiple Ipsilateral Breast Cancer: An Initial Report from ACOSOG Z11102 (Alliance) Trial. Ann Surg Oncol 25:2858-2866

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