The Data Management core activities are performed by the Data Management Center of the ECOG- ACRIN Statistics and Data Management Center. The Data Management Center is responsible for collection and processing of data on ECOG-ACRIN studies and for related information systems support. The Center has two components. SDMC-EAMRF at the ECOG-ACRCIN Medical Research Foundation has primary responsibility for therapeutic studies. The SDMC-ACR at the American College of Radiology has primary responsibility for diagnostic and imaging studies. All clinical data on studies activated since the start of the NCTN is collected and managed in Medidata Rave, the NCTN's common Clinical Data Management System. ECOG-ACRIN has been a leader in developing configuration standards and operational procedures for using Rave in the NCTN. Data review procedures are well developed and include clinical review, which is usually performed by study chairs. The Data Management core has established extensive education and training programs for site personnel and investigators. These training programs are an important part of ensuring timely and accurate data submission and review. The data management core has also developed reports for monitoring site performance regarding timeliness and accuracy of data submission, and works with the ECOG-ACRIN Operations on the annual institution evaluation. The Statistics and Data Management Center also fully utilizes standard NCTN tools, such as the Oncology Patient Enrollment Network (the web interface for patient enrollment on NCTN studies), the Cancer Data Standards Repository library of standardized data elements, the common toxicity criteria for adverse events, the CTEP-AERS system for adverse event reporting, which is being integrated into Rave), and the Clinical Data Update System for reporting selected trial and patient data to NCI. The Information Systems group maintains multiple databases, develops and maintains tools for monitoring, reporting, and communication, and has developed infrastructure to support complex trials such as NCI- MATCH.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10CA180794-06
Application #
9627515
Study Section
Special Emphasis Panel (ZCA1)
Project Start
Project End
Budget Start
2019-04-04
Budget End
2020-02-29
Support Year
6
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Dana-Farber Cancer Institute
Department
Type
DUNS #
076580745
City
Boston
State
MA
Country
United States
Zip Code
02215
Meropol, Neal J; Feng, Yang; Grem, Jean L et al. (2018) Phase 2 study of treatment selection based on tumor thymidylate synthase expression in previously untreated patients with metastatic colorectal cancer: A trial of the ECOG-ACRIN Cancer Research Group (E4203). Cancer 124:688-697
Miller, Kathy D; O'Neill, Anne; Gradishar, William et al. (2018) Double-Blind Phase III Trial of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer (E5103). J Clin Oncol 36:2621-2629
Sparano, Joseph A; Gray, Robert J; Makower, Della F et al. (2018) Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med 379:111-121
Kyriakopoulos, Christos E; Chen, Yu-Hui; Carducci, Michael A et al. (2018) Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. J Clin Oncol 36:1080-1087
Zhao, Fengmin; Cella, David; Manola, Judith et al. (2018) Fatigue among patients with renal cell carcinoma receiving adjuvant sunitinib or sorafenib: patient-reported outcomes of ECOG-ACRIN E2805 trial. Support Care Cancer 26:1889-1895
Berlin, Jordan D; Feng, Yang; Catalano, Paul et al. (2018) An Intergroup Randomized Phase II Study of Bevacizumab or Cetuximab in Combination with Gemcitabine and in Combination with Chemoradiation in Patients with Resected Pancreatic Carcinoma: A Trial of the ECOG-ACRIN Cancer Research Group (E2204). Oncology 94:39-46
Gravis, Gwenaelle; Boher, Jean-Marie; Chen, Yu-Hui et al. (2018) Burden of Metastatic Castrate Naive Prostate Cancer Patients, to Identify Men More Likely to Benefit from Early Docetaxel: Further Analyses of CHAARTED and GETUG-AFU15 Studies. Eur Urol 73:847-855
Swinnen, Lode J; O'Neill, Anne; Imus, Philip H et al. (2018) Phase II study of rituximab given in conjunction with standard chemotherapy in primary central nervous system lymphoma (PCNSL): a trial of the ECOG-ACRIN cancer research group (E1F05). Oncotarget 9:766-773
Estabrook, Ryne; Cella, David; Zhao, Fengmin et al. (2018) Longitudinal and dynamic measurement invariance of the FACIT-Fatigue scale: an application of the measurement model of derivatives to ECOG-ACRIN study E2805. Qual Life Res 27:1589-1597
Harshman, Lauren C; Chen, Yu-Hui; Liu, Glenn et al. (2018) Seven-Month Prostate-Specific Antigen Is Prognostic in Metastatic Hormone-Sensitive Prostate Cancer Treated With Androgen Deprivation With or Without Docetaxel. J Clin Oncol 36:376-382

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