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
Jin, Honglei; Yu, Yonghui; Hu, Young et al. (2015) Divergent behaviors and underlying mechanisms of cell migration and invasion in non-metastatic T24 and its metastatic derivative T24T bladder cancer cell lines. Oncotarget 6:522-36
Zhou, Sherry; Weitzman, Michael; Vilcassim, Ruzmyn et al. (2015) Air quality in New York City hookah bars. Tob Control 24:e193-8
Brocato, Jason; Costa, Max (2015) 10th NTES Conference: Nickel and arsenic compounds alter the epigenome of peripheral blood mononuclear cells. J Trace Elem Med Biol 31:209-13
Cohen, Mitchell D; Vaughan, Joshua M; Garrett, Brittany et al. (2015) Acute high-level exposure to WTC particles alters expression of genes associated with oxidative stress and immune function in the lung. J Immunotoxicol 12:140-53
Ota, Mitsuhiko; Horiguchi, Masahito; Fang, Victoria et al. (2014) Genetic suppression of inflammation blocks the tumor-promoting effects of TGF-? in gastric tissue. Cancer Res 74:2642-51
McKinney, Caleb; Zavadil, Jiri; Bianco, Christopher et al. (2014) Global reprogramming of the cellular translational landscape facilitates cytomegalovirus replication. Cell Rep 6:9-17
Vazquez-Cintron, Edwin J; Vakulenko, Maksim; Band, Philip A et al. (2014) Atoxic derivative of botulinum neurotoxin A as a prototype molecular vehicle for targeted delivery to the neuronal cytoplasm. PLoS One 9:e85517
Jhaveri, Komal; Chandarlapaty, Sarat; Lake, Diana et al. (2014) A phase II open-label study of ganetespib, a novel heat shock protein 90 inhibitor for patients with metastatic breast cancer. Clin Breast Cancer 14:154-60
Wu, Meng; Yang, Feikun; Ren, Zhihua et al. (2014) Identification of the nuclear localization signal of SALL4B, a stem cell transcription factor. Cell Cycle 13:1456-62
Kaneko, Syuzo; Bonasio, Roberto; SaldaƱa-Meyer, Ricardo et al. (2014) Interactions between JARID2 and noncoding RNAs regulate PRC2 recruitment to chromatin. Mol Cell 53:290-300

Showing the most recent 10 out of 491 publications