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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA180882-02
Application #
8839742
Study Section
Special Emphasis Panel (ZCA1-GRB-I (O1))
Program Officer
Mooney, Margaret M
Project Start
2014-04-17
Project End
2019-02-28
Budget Start
2015-03-01
Budget End
2016-02-29
Support Year
2
Fiscal Year
2015
Total Cost
$6,542,682
Indirect Cost
$1,364,190
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905
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
Rizzotto, Lara; Lai, Tzung-Huei; Bottoni, Arianna et al. (2018) Role and regulation of microRNAs targeting BTK in acute myelogenous leukemia. Leuk Lymphoma 59:1461-1465
Straus, David J; Jung, Sin-Ho; Pitcher, Brandelyn et al. (2018) CALGB 50604: risk-adapted treatment of nonbulky early-stage Hodgkin lymphoma based on interim PET. Blood 132:1013-1021
Rashkin, Sara R; Chua, Katherina C; Ho, Carol et al. (2018) A Pharmacogenetic Prediction Model of Progression-Free Survival in Breast Cancer using Genome-Wide Genotyping Data from CALGB 40502 (Alliance). Clin Pharmacol Ther :
Li, Daneng; McCall, Linda M; Hahn, Olwen M et al. (2018) Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study. Breast Cancer Res Treat 171:325-334
Grothey, Axel; Sobrero, Alberto F; Shields, Anthony F et al. (2018) Duration of Adjuvant Chemotherapy for Stage III Colon Cancer. N Engl J Med 378:1177-1188
Schiff, David; Jaeckle, Kurt A; Anderson, S Keith et al. (2018) Phase 1/2 trial of temsirolimus and sorafenib in the treatment of patients with recurrent glioblastoma: North Central Cancer Treatment Group Study/Alliance N0572. Cancer 124:1455-1463
McWilliams, Robert R; Allred, Jacob B; Slostad, Jessica A et al. (2018) NCCTG N0879 (Alliance): A randomized phase 2 cooperative group trial of carboplatin, paclitaxel, and bevacizumab?±?everolimus for metastatic melanoma. Cancer 124:537-545
Guercio, Brendan J; Zhang, Sui; Niedzwiecki, Donna et al. (2018) Associations of artificially sweetened beverage intake with disease recurrence and mortality in stage III colon cancer: Results from CALGB 89803 (Alliance). PLoS One 13:e0199244

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