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 #
2P30CA016087-33
Application #
8436456
Study Section
Subcommittee G - Education (NCI)
Project Start
2013-03-01
Project End
2018-02-28
Budget Start
2013-04-01
Budget End
2014-02-28
Support Year
33
Fiscal Year
2013
Total Cost
$28,531
Indirect Cost
$11,698

  Institution

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

  Publications

Snetkova, Valentina; Skok, Jane A (2018) Enhancer talk. Epigenomics 10:483-498
Litwinoff, Evelyn M S; Gold, Merav Y; Singh, Karan et al. (2018) Myeloid ATG16L1 does not affect adipose tissue inflammation or body mass in mice fed high fat diet. Obes Res Clin Pract 12:174-186
Lee, Chul-Hwan; Holder, Marlene; Grau, Daniel et al. (2018) Distinct Stimulatory Mechanisms Regulate the Catalytic Activity of Polycomb Repressive Complex 2. Mol Cell 70:435-448.e5
Fan, Xiaozhou; Alekseyenko, Alexander V; Wu, Jing et al. (2018) Human oral microbiome and prospective risk for pancreatic cancer: a population-based nested case-control study. Gut 67:120-127
Gregory, Ann C; Sullivan, Matthew B; Segal, Leopoldo N et al. (2018) Smoking is associated with quantifiable differences in the human lung DNA virome and metabolome. Respir Res 19:174
Taylor, Martin S; Altukhov, Ilya; Molloy, Kelly R et al. (2018) Dissection of affinity captured LINE-1 macromolecular complexes. Elife 7:
Bertrand, Anne; Baron, Maria; Hoang, Dung M et al. (2018) In Vivo Evaluation of Neuronal Transport in Murine Models of Neurodegeneration Using Manganese-Enhanced MRI. Methods Mol Biol 1779:527-541
Jung, Seungyoun; Allen, Naomi; Arslan, Alan A et al. (2018) Anti-Müllerian hormone and risk of ovarian cancer in nine cohorts. Int J Cancer 142:262-270
Wang, Sophia S; Carrington, Mary; Berndt, Sonja I et al. (2018) HLA Class I and II Diversity Contributes to the Etiologic Heterogeneity of Non-Hodgkin Lymphoma Subtypes. Cancer Res 78:4086-4096
Kirkling, Margaret E; Cytlak, Urszula; Lau, Colleen M et al. (2018) Notch Signaling Facilitates In Vitro Generation of Cross-Presenting Classical Dendritic Cells. Cell Rep 23:3658-3672.e6

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