Overall Component The SWOG Statistics and Data Management Center (SDMC) provides leadership in the statistical design, data management, analysis, and reporting of NCTN clinical trials. It contributes to SWOG's overall mission to significantly improve lives through cancer clinical trials and translational research. The goals of the SDMC are to (a) rapidly design, develop, and implement rigorous and efficient multi-center clinical trials; (b) enhance systems for best monitoring of ongoing trials and ensure reproducibility of research using cross-study standardized software and systems for statistical analysis and clinical trials reporting; (c) develop innovative statistical design and software tools for incorporating integral and integrated biomarkers into clinical trials; (d) collaborate with other researchers on statistical methods research, including clinical trial design and the analysis of translational medicine studies, with a focus on precision medicine and challenges in the evaluation of immunotherapy; (e) investigate new strategies for enhancing NCTN data by constructing linkages to external databases and building a comprehensive repository of SWOG clinical and translational medicine data; and (f) advance the science of the NCTN program and the National Cancer Institute research agenda, in partnership with other NCTN investigators, by providing scientific leadership through participation in activities such as steering committees, working groups, task forces, data sharing, and clinical science meetings. The SWOG SDMC contributes to the goals of SWOG and partners with the NCTN to conduct trials within the current portfolio, while also providing data, strategies, and useful new statistical tools to other clinical trials organizations and oncology researchers.

Public Health Relevance

Well-designed and well-conducted clinical trials are the primary means for evaluating new cancer therapies, advancing cures, reducing morbidity and mortality, and improving patient outcomes. The SWOG SDMC aims to be a leader in innovative trial design and analysis of science-driven publically funded Phase II and Phase III trials and translational medicine studies. Furthermore, our timely and high-quality trial implementation, management, and reporting ensure that the results of clinical trials have the greatest potential impact on cancer patients.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA180819-08
Application #
10107777
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Mooney, Margaret M
Project Start
2014-04-17
Project End
2025-02-28
Budget Start
2021-03-01
Budget End
2022-02-28
Support Year
8
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Mongiovi, Jennifer M; Zirpoli, Gary R; Cannioto, Rikki et al. (2018) Associations between self-reported diet during treatment and chemotherapy-induced peripheral neuropathy in a cooperative group trial (S0221). Breast Cancer Res 20:146
Halpern, Anna B; Othus, Megan; Huebner, Emily M et al. (2018) Phase 1/2 trial of GCLAM with dose-escalated mitoxantrone for newly diagnosed AML or other high-grade myeloid neoplasms. Leukemia :
Messing, Edward M; Tangen, Catherine M; Lerner, Seth P et al. (2018) Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial. JAMA 319:1880-1888
Smith, Eileen P; Li, Hongli; Friedberg, Jonathan W et al. (2018) Tandem Autologous Hematopoietic Cell Transplantation for Patients with Primary Progressive or Recurrent Hodgkin Lymphoma: A SWOG and Blood and Marrow Transplant Clinical Trials Network Phase II Trial (SWOG S0410/BMT CTN 0703). Biol Blood Marrow Transplant 24:700-707
Unger, Joseph M; Vaidya, Riha; Gore, John L (2018) Key design and analysis principles for quality of life and patient-reported outcomes in clinical trials. Urol Oncol :
Cheng, Ting-Yuan David; Darke, Amy K; Redman, Mary W et al. (2018) Smoking, Sex, and Non-Small Cell Lung Cancer: Steroid Hormone Receptors in Tumor Tissue (S0424). J Natl Cancer Inst 110:734-742
West, Howard L; Moon, James; Wozniak, Antoinette J et al. (2018) Paired Phase II Studies of Erlotinib/Bevacizumab for Advanced Bronchioloalveolar Carcinoma or Never Smokers With Advanced Non-Small-cell Lung Cancer: SWOG S0635 and S0636 Trials. Clin Lung Cancer 19:84-92
Walter, Roland B; Michaelis, Laura C; Othus, Megan et al. (2018) Intergroup LEAP trial (S1612): A randomized phase 2/3 platform trial to test novel therapeutics in medically less fit older adults with acute myeloid leukemia. Am J Hematol 93:E49-E52
Othus, Megan; Estey, Elihu H; Garcia-Manero, Guillermo et al. (2018) Second cycle remission achievement with 7+3 and survival in adults with newly diagnosed acute myeloid leukemia: analysis of recent SWOG trials. Leukemia :
Hussain, Maha; Tangen, Catherine M; Thompson Jr, Ian M et al. (2018) Phase III Intergroup Trial of Adjuvant Androgen Deprivation With or Without Mitoxantrone Plus Prednisone in Patients With High-Risk Prostate Cancer After Radical Prostatectomy: SWOG S9921. J Clin Oncol 36:1498-1504

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