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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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
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
Innocenti, Federico; Jiang, Chen; Sibley, Alexander B et al. (2018) Genetic variation determines VEGF-A plasma levels in cancer patients. Sci Rep 8:16332
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
Basch, Ethan; Dueck, Amylou C; Rogak, Lauren J et al. (2018) Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048. J Clin Oncol :JCO2018788620
Vera Aguilera, Jesus; Rao, Ravi D; Allred, Jacob B et al. (2018) Phase II Study of Everolimus in Metastatic Malignant Melanoma (NCCTG-N0377, Alliance). Oncologist 23:887-e94
Innocenti, Federico; Owzar, Kouros; Jiang, Chen et al. (2018) The vitamin D receptor gene as a determinant of survival in pancreatic cancer patients: Genomic analysis and experimental validation. PLoS One 13:e0202272
Tanioka, Maki; Fan, Cheng; Parker, Joel S et al. (2018) Integrated Analysis of RNA and DNA from the Phase III Trial CALGB 40601 Identifies Predictors of Response to Trastuzumab-Based Neoadjuvant Chemotherapy in HER2-Positive Breast Cancer. Clin Cancer Res 24:5292-5304
Van Blarigan, Erin L; Ou, Fang-Shu; Niedzwiecki, Donna et al. (2018) Dietary Fat Intake after Colon Cancer Diagnosis in Relation to Cancer Recurrence and Survival: CALGB 89803 (Alliance). Cancer Epidemiol Biomarkers Prev 27:1227-1230
Magbanua, Mark Jesus M; Rugo, Hope S; Wolf, Denise M et al. (2018) Expanded Genomic Profiling of Circulating Tumor Cells in Metastatic Breast Cancer Patients to Assess Biomarker Status and Biology Over Time (CALGB 40502 and CALGB 40503, Alliance). Clin Cancer Res 24:1486-1499

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