The Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) has developed a robust system for data and safety monitoring, accomplished through the collaborative efforts of the three committees of the Clinical Protocol Scientific Review and Monitoring System (CPSRMS). These committees are: the Scientific Review Committee (SRC), the Data Monitoring Committee (DMC), and the Clinical Trial Audit Committee (CTAC). These committees are responsible for administering the Lurie Cancer Center's Data and Safety Monitoring Plan (DSMP), which was originally approved by the NCI in August of 2001, and has since undergone 10 revisions. The most recent revision to the plan was submitted to the NCI in May of 2012 and was accepted without comment at that time. In the previous competing CCSG application the assessment of Data and Safety Monitoring resulted in an Acceptable [Approved] status with no deficiencies noted. However, in section 9.2 PRMS, the previous CCSG competing submission included comments in the critique that relate directly to data and safety monitoring. First, it was suggested that the CTAC expand the auditing program to be more comprehensive. This has been done, and the audit strategy is described below. The second comment relates to DMC review for phase I studies and offered that a medical monitor may provide greater oversight for these trials if our phase I studies increase in number. A significant increase has not been seen, so this change has not been made, however both the SRC and DMC are mindful of and appreciate this recommendation. If our phase I program increases substantially, this change will be considered.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA060553-20
Application #
8761081
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
20
Fiscal Year
2014
Total Cost
$34,153
Indirect Cost
$11,948
Name
Northwestern University at Chicago
Department
Type
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611
Yang, Ruiguo; LemaƮtre, Vincent; Huang, Changjin et al. (2018) Monoclonal Cell Line Generation and CRISPR/Cas9 Manipulation via Single-Cell Electroporation. Small 14:e1702495
Buglak, Nicholas E; Jiang, Wulin; Bahnson, Edward S M (2018) Cinnamic aldehyde inhibits vascular smooth muscle cell proliferation and neointimal hyperplasia in Zucker Diabetic Fatty rats. Redox Biol 19:166-178
Takahashi, Satoe; Sun, Willy; Zhou, Yingjie et al. (2018) Prestin Contributes to Membrane Compartmentalization and Is Required for Normal Innervation of Outer Hair Cells. Front Cell Neurosci 12:211
Zheng, Jianbin; Chen, Long; Skinner, Owen S et al. (2018) ?-Glucocerebrosidase Modulators Promote Dimerization of ?-Glucocerebrosidase and Reveal an Allosteric Binding Site. J Am Chem Soc 140:5914-5924
Kenney, Grace E; Dassama, Laura M K; Pandelia, Maria-Eirini et al. (2018) The biosynthesis of methanobactin. Science 359:1411-1416
Joyce, Brian T; Zheng, Yinan; Zhang, Zhou et al. (2018) miRNA-Processing Gene Methylation and Cancer Risk. Cancer Epidemiol Biomarkers Prev 27:550-557
Chu, Lan H; Indramohan, Mohanalaxmi; Ratsimandresy, Rojo A et al. (2018) The oxidized phospholipid oxPAPC protects from septic shock by targeting the non-canonical inflammasome in macrophages. Nat Commun 9:996
Symes, Yael R; Barrington, Clare; Austin, Jane et al. (2018) Advice to patients undergoing stem cell transplant: Content analysis of survivor peer support narratives. J Health Psychol 23:818-828
Lewis, Phillip L; Green, Richard M; Shah, Ramille N (2018) 3D-printed gelatin scaffolds of differing pore geometry modulate hepatocyte function and gene expression. Acta Biomater 69:63-70
Ugolkov, Andrey V; Bondarenko, Gennadiy I; Dubrovskyi, Oleksii et al. (2018) 9-ING-41, a small-molecule glycogen synthase kinase-3 inhibitor, is active in neuroblastoma. Anticancer Drugs 29:717-724

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