Clinical Trials Office and Data and Safety Monitoring (DSM) Description The Masonic Cancer Center (MCC) Clinical Trials Office (CTO) was formally established in 2001 with the goal of enhancing MCC members'ability to conduct clinical cancer research by providing centralized and specialized resources and expertise. It assists MCC investigators in developing, activating, and completing scientifically meritorious clinical trials in a high-quality, efficient, cost-effective, centralized manner. At the same time, it ensures the validity and integrity of data in order to fulfill all NCI, federal, and local regulatory requirements. In fiscal year 2012, the CTO opened 42 clinical trials to accrual. As of July 2012, 296 active clinical trials were using CTO services, of which 134 were investigator initiated, 82 were National Cooperative Group trials, and 80 were industry trials. The CTO is currently managing 27 Investigational New Drug Application (IND)/lnvestigational Device Exemption (IDE) trials. A total of 1220 patients (active treatment and follow-up) are currently being followed by the CTO. The CTO focuses on investigator-initiated trials and the translation of basic scientific findings to clinical trials, effectively leveraging MCC resources for the management of our therapeutic translational pipeline. The CTO provides the following major areas of support to MCC investigators: clinical services and data management, regulatory affairs, and Clinical Trials Reporting Program registrations and updates, protocol development, clinical trial finance management, project management, system management, clinical trial monitoring and auditing. The MCC Data and Safety Monitoring Plan (DSMP) details the roles and responsibilities of 3 accountable units (PI, MCC, and the University of Minnesota) and the processes that are used by these accountable units to ensure that the highest-quality clinical research is conducted while participant safety is optimized. The current DSMP was approved by the NCI on February 16, 2012. The PI is responsible for all aspects of trial conduct, including clinical trial management, data acquisition, and data and safety monitoring. The MCC has the responsibility of clinical research oversight. The University has oversight for conflict of interest and regulatory standards.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Minnesota Twin Cities
United States
Zip Code
Lin, Lifeng; Chu, Haitao; Murad, Mohammad Hassan et al. (2018) Empirical Comparison of Publication Bias Tests in Meta-Analysis. J Gen Intern Med 33:1260-1267
Rashidi, Armin; Ebadi, Maryam; Said, Bassil et al. (2018) Absence of early HHV-6 reactivation after cord blood allograft predicts powerful graft-versus-tumor effect. Am J Hematol :
Bejanyan, Nelli; Brunstein, Claudio G; Cao, Qing et al. (2018) Delayed immune reconstitution after allogeneic transplantation increases the risks of mortality and chronic GVHD. Blood Adv 2:909-922
Bachanova, Veronika; Sarhan, Dhifaf; DeFor, Todd E et al. (2018) Haploidentical natural killer cells induce remissions in non-Hodgkin lymphoma patients with low levels of immune-suppressor cells. Cancer Immunol Immunother 67:483-494
Hupp, Meghan; Williams, Sarah; Dunnette, Brian et al. (2018) Comparison of evaluation techniques, including digital image analysis, for MYC protein expression by immunohistochemical stain in aggressive B-cell lymphomas. Hum Pathol :
Rashidi, Armin; Shanley, Ryan; Holtan, Shernan G et al. (2018) Pretransplant Serum Citrulline Predicts Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant 24:2190-2196
Ma, Bin; Zarth, Adam T; Carlson, Erik S et al. (2018) Methyl DNA Phosphate Adduct Formation in Rats Treated Chronically with 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone and Enantiomers of Its Metabolite 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol. Chem Res Toxicol 31:48-57
Hatsukami, Dorothy K; Luo, Xianghua; Jensen, Joni A et al. (2018) Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure: A Randomized Clinical Trial. JAMA 320:880-891
Lee, Hak Rae; Leslie, Faith; Azarin, Samira M (2018) A facile in vitro platform to study cancer cell dormancy under hypoxic microenvironments using CoCl2. J Biol Eng 12:12
Yang, Libang; Herrera, Jeremy; Gilbertsen, Adam et al. (2018) IL-8 mediates idiopathic pulmonary fibrosis mesenchymal progenitor cell fibrogenicity. Am J Physiol Lung Cell Mol Physiol 314:L127-L136

Showing the most recent 10 out of 1013 publications