Abstract

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.

  Funding 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

  Institution

Name
New York University
Department
Type
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016

  Publications

Berger, Ashton C; Korkut, Anil; Kanchi, Rupa S et al. (2018) A Comprehensive Pan-Cancer Molecular Study of Gynecologic and Breast Cancers. Cancer Cell 33:690-705.e9
Harper, Lamia; Balasubramanian, Divya; Ohneck, Elizabeth A et al. (2018) Staphylococcus aureus Responds to the Central Metabolite Pyruvate To Regulate Virulence. MBio 9:
Gowen, Michael F; Giles, Keith M; Simpson, Danny et al. (2018) Baseline antibody profiles predict toxicity in melanoma patients treated with immune checkpoint inhibitors. J Transl Med 16:82
Llewellyn, Sean R; Britton, Graham J; Contijoch, Eduardo J et al. (2018) Interactions Between Diet and the Intestinal Microbiota Alter Intestinal Permeability and Colitis Severity in Mice. Gastroenterology 154:1037-1046.e2
Pelzek, Adam J; Shopsin, Bo; Radke, Emily E et al. (2018) Human Memory B Cells Targeting Staphylococcus aureus Exotoxins Are Prevalent with Skin and Soft Tissue Infection. MBio 9:
Chiou, Kenneth L; Bergey, Christina M (2018) Methylation-based enrichment facilitates low-cost, noninvasive genomic scale sequencing of populations from feces. Sci Rep 8:1975
Jose, Cynthia C; Jagannathan, Lakshmanan; Tanwar, Vinay S et al. (2018) Nickel exposure induces persistent mesenchymal phenotype in human lung epithelial cells through epigenetic activation of ZEB1. Mol Carcinog 57:794-806
Kourtis, Nikos; Lazaris, Charalampos; Hockemeyer, Kathryn et al. (2018) Oncogenic hijacking of the stress response machinery in T cell acute lymphoblastic leukemia. Nat Med 24:1157-1166
Formenti, Silvia C; Lee, Percy; Adams, Sylvia et al. (2018) Focal Irradiation and Systemic TGF? Blockade in Metastatic Breast Cancer. Clin Cancer Res 24:2493-2504
Snuderl, Matija; Kannan, Kasthuri; Pfaff, Elke et al. (2018) Recurrent homozygous deletion of DROSHA and microduplication of PDE4DIP in pineoblastoma. Nat Commun 9:2868

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