The Data and Safety Monitoring Committee (DSMC) of the NYU Cancer Institute (NYUCI) operates based on the Data and Safety Monitoring Plan approved by the NCI in November 2011 and the highest priority is placed on ensuring the safety of patients who enroll on clinical trials. The DSMC is a multidisciplinary committee composed of clinical investigators, biostatisticians and research administrative staff from the Clinical Trials Office (CTO), all with expertise in research methodology and the conduct of clinical trials. The DSMC reports to the Director of the NYUCI (WilHam L. Carroll, MD). The DSMC oversees the conduct of institutional trials. In addition, the NYUCI Internal Audit Committee and Phase I/II Committee review all Investigator-Initiated trials or Multi-Center Trials which NYUCI is the coordinating center. The lAC is a quality assurance mechanism to assess compliance with protocol procedures and data integrity, FDA regulations and CTO policy. Phase I/II Committee provides a mechanism to more closely monitor accrual, timeliness of data collections, adverse events and the available resources needed to achieve study endpoints.

Public Health Relevance

The DSMC is responsible for monitoring safety, conduct and compliance with protocol data monitoring plans for clinical trials conducted within the NYUCI that are not monitored by any other institution or agency.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA016087-34
Application #
8765188
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-03-01
Budget End
2015-02-28
Support Year
34
Fiscal Year
2014
Total Cost
$19,789
Indirect Cost
$8,114
Name
New York University
Department
Type
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
Saint Fleur-Lominy, Shella; Maus, Mate; Vaeth, Martin et al. (2018) STIM1 and STIM2 Mediate Cancer-Induced Inflammation in T Cell Acute Lymphoblastic Leukemia. Cell Rep 24:3045-3060.e5
Puranik, Amrutesh S; Leaf, Irina A; Jensen, Mark A et al. (2018) Kidney-resident macrophages promote a proangiogenic environment in the normal and chronically ischemic mouse kidney. Sci Rep 8:13948
Cui, Xin; Morales, Renee-Tyler Tan; Qian, Weiyi et al. (2018) Hacking macrophage-associated immunosuppression for regulating glioblastoma angiogenesis. Biomaterials 161:164-178
Weng, Mao-Wen; Lee, Hyun-Wook; Park, Sung-Hyun et al. (2018) Aldehydes are the predominant forces inducing DNA damage and inhibiting DNA repair in tobacco smoke carcinogenesis. Proc Natl Acad Sci U S A 115:E6152-E6161
Burgess, Hannah M; Pourchet, Aldo; Hajdu, Cristina H et al. (2018) Targeting Poxvirus Decapping Enzymes and mRNA Decay to Generate an Effective Oncolytic Virus. Mol Ther Oncolytics 8:71-81
Wong, Serre-Yu; Coffre, Maryaline; Ramanan, Deepshika et al. (2018) B Cell Defects Observed in Nod2 Knockout Mice Are a Consequence of a Dock2 Mutation Frequently Found in Inbred Strains. J Immunol 201:1442-1451
Handler, Jesse; Cullis, Jane; Avanzi, Antonina et al. (2018) Pre-neoplastic pancreas cells enter a partially mesenchymal state following transient TGF-? exposure. Oncogene 37:4334-4342
Diamond, Julie M; Vanpouille-Box, Claire; Spada, Sheila et al. (2018) Exosomes Shuttle TREX1-Sensitive IFN-Stimulatory dsDNA from Irradiated Cancer Cells to DCs. Cancer Immunol Res 6:910-920
Fan, Xiaozhou; Peters, Brandilyn A; Jacobs, Eric J et al. (2018) Drinking alcohol is associated with variation in the human oral microbiome in a large study of American adults. Microbiome 6:59
Chen, Danqi; Fang, Lei; Mei, Shenglin et al. (2018) Erratum: ""Regulation of Chromatin Assembly and Cell Transformation by Formaldehyde Exposure in Human Cells"". Environ Health Perspect 126:019001

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