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.
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.
|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|
|Lei, Jonathan T; Shao, Jieya; Zhang, Jin et al. (2018) Functional Annotation of ESR1 Gene Fusions in Estrogen Receptor-Positive Breast Cancer. Cell Rep 24:1434-1444.e7|
|Neuman, Heather B; Schumacher, Jessica R; Francescatti, Amanda B et al. (2018) Risk of Synchronous Distant Recurrence at Time of Locoregional Recurrence in Patients With Stage II and III Breast Cancer (AFT-01). J Clin Oncol 36:975-980|
|Van Blarigan, Erin L; Fuchs, Charles S; Niedzwiecki, Donna et al. (2018) Marine ?-3 Polyunsaturated Fatty Acid and Fish Intake after Colon Cancer Diagnosis and Survival: CALGB 89803 (Alliance). Cancer Epidemiol Biomarkers Prev 27:438-445|
|Galanis, Evanthia; Anderson, S Keith; Miller, C Ryan et al. (2018) Phase I/II trial of vorinostat combined with temozolomide and radiation therapy for newly diagnosed glioblastoma: results of Alliance N0874/ABTC 02. Neuro Oncol 20:546-556|
|Roboz, Gail J; Mandrekar, Sumithra J; Desai, Pinkal et al. (2018) Randomized trial of 10 days of decitabine ± bortezomib in untreated older patients with AML: CALGB 11002 (Alliance). Blood Adv 2:3608-3617|
|Altorki, Nasser K; Wang, Xiaofei; Wigle, Dennis et al. (2018) Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 trial (CALGB/Alliance 140503). Lancet Respir Med :|
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