Data Safety Monitoring Committee (DSMC) of the NYU Cancer Institute operates based on the 2001 NCI approved Charter. The DSMC reports to the NYU Cancer Institute Clinical Cancer Investigation Committee (W. Carroll, M.D. Chair;Deputy Director of NYUCI). The DSMC is responsible for monitoring safety, conduct and compliance with protocol data monitoring plans for clinical trials in the Cancer Institute that are not monitored by any other institution or agency, and review of all internal serious adverse events on clinical trials in the Cancer Institute. The scope of this internal DSMC review includes Phase I, Phase II, and Phase I/II studies that are: ? NYU Investigator - Initiated protocols ? NCI Protocols-not reviewed by NCI ? NY GOG - NYU coordinating site The DSMC is composed of clinical investigators/oncologists who are members of the NYUCI, and biostatisticians from the Biostatistics Shared Resource (BSR) who are experts in clinical trial methodology and conduct. The DSMC is supported by staff from the BSR and Clinical Trials Office (CTO). Table 1 lists the members of the DSMC and the staff. The membership of the DSMC is designed to ensure that should there be a conflict of interest for the Chair because of her role on a specific clinical trial, then the Deputy Chair takes over. The same is true for the Oncology members. Additional ad hoc members are also recruited as needed. The DSMC meets monthly to review ongoing clinical trials. This monthly review includes monitoring of three aspects of the protocol: study conduct, safety, and compliance with the data safety monitoring plan. Monitoring for study conduct includes review of: accrual rates, eligibility, compliance, protocol violations, and dropouts. Monitoring for safety includes review of: adverse events (AEs), treatment related AEs, serious adverse events (SAEs), and, for phase I studies, dose limiting toxicities (DLTs). For Phase II studies, compliance with the protocol defined stopping rules is also reviewed along with the results of planned interim analyses. All reviews are based on data provided to the Committee by the Principal Investigator and the CTO. Verification of accuracy of data is conducted by the Internal Audit Committee and editing and validation procedures implemented as part of the data management processes and procedures.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA016087-32
Application #
8376811
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
2013-02-28
Budget Start
2012-03-01
Budget End
2013-02-28
Support Year
32
Fiscal Year
2012
Total Cost
$53,666
Indirect Cost
$23,458
Name
New York University
Department
Type
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
Huang, Chao; Zeng, Xingruo; Jiang, Guosong et al. (2017) XIAP BIR domain suppresses miR-200a expression and subsequently promotes EGFR protein translation and anchorage-independent growth of bladder cancer cell. J Hematol Oncol 10:6
Silvera, Deborah; Ernlund, Amanda; Arju, Rezina et al. (2017) mTORC1 and -2 Coordinate Transcriptional and Translational Reprogramming in Resistance to DNA Damage and Replicative Stress in Breast Cancer Cells. Mol Cell Biol 37:
Koh, Hyunwook; Blaser, Martin J; Li, Huilin (2017) A powerful microbiome-based association test and a microbial taxa discovery framework for comprehensive association mapping. Microbiome 5:45
Ma, Lijie; Liu, Yan; Landry, Nichole K et al. (2017) Point mutation in D8C domain of Tamm-Horsfall protein/uromodulin in transgenic mice causes progressive renal damage and hyperuricemia. PLoS One 12:e0186769
Morabito, Michael V; Ravussin, Yann; Mueller, Bridget R et al. (2017) Weight Perturbation Alters Leptin Signal Transduction in a Region-Specific Manner throughout the Brain. PLoS One 12:e0168226
Koetz-Ploch, Lisa; Hanniford, Douglas; Dolgalev, Igor et al. (2017) MicroRNA-125a promotes resistance to BRAF inhibitors through suppression of the intrinsic apoptotic pathway. Pigment Cell Melanoma Res 30:328-338
Feig, Jessica L; Mediero, Aranzazu; Corciulo, Carmen et al. (2017) The antiviral drug tenofovir, an inhibitor of Pannexin-1-mediated ATP release, prevents liver and skin fibrosis by downregulating adenosine levels in the liver and skin. PLoS One 12:e0188135
Ono, Kentaro; Viet, Chi T; Ye, Yi et al. (2017) Cutaneous pigmentation modulates skin sensitivity via tyrosinase-dependent dopaminergic signalling. Sci Rep 7:9181
Wang, Xing; Zhang, Fenglin; Wu, Xue-Ru (2017) Inhibition of Pyruvate Kinase M2 Markedly Reduces Chemoresistance of Advanced Bladder Cancer to Cisplatin. Sci Rep 7:45983
Garré, Juan Mauricio; Silva, Hernandez Moura; Lafaille, Juan J et al. (2017) CX3CR1+ monocytes modulate learning and learning-dependent dendritic spine remodeling via TNF-?. Nat Med 23:714-722

Showing the most recent 10 out of 1082 publications