Abstract

DATA AND SAFETY MONITORING The Data and Safety Monitoring Plan (DSMP) of the Kimmel Cancer Center (KCC) provides for the oversight and monitoring of clinical trials to ensure the: 1. Safety of patients;and 2. Validity and integrity of the data collected on these trials. Responsibility for data and safety monitoring at Thomas Jefferson University (TJU) resides in: 1. The Clinical Cancer Research Review Committee (CCRRC) which oversees the scientific review of all new and ongoing cancer-related clinical trials within the KCC; 2. The Clinical Research Management Office (CRMO) which provides strategic assistance and support to the CCRRC, DSMC, and continuous monitoring; 3. The Institutional Review Board (IRB) which has primary responsibility for the protection of the welfare of human subjects involved in biomedical and behavioral research. The IRB has full authority to approve, request modifications prior to approval, disapprove, suspend, or terminate for cause all research activities that fall within its jurisdiction;and 4. The Data and Safety Monitoring Committee (DSMC), which is responsible for data and safety monitoring of Kimmel Cancer Center investigator-initiated trials (KCC IIT).

Public Health Relevance

The DSMP requires that every Kimmel Cancer Center protocol include a data and safefy monitoring plan. The CCRRC will not review a study that does not have such a plan, and the TJU IRB will not accept a study for review and approval until it has been approved by the CCRRC

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA056036-14
Application #
8517975
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-07-15
Project End
2018-05-31
Budget Start
2013-06-18
Budget End
2014-05-31
Support Year
14
Fiscal Year
2013
Total Cost
$206,390
Indirect Cost
$73,123

  Institution

Name
Thomas Jefferson University
Department
Type
DUNS #
053284659
City
Philadelphia
State
PA
Country
United States
Zip Code
19107

  Publications

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Magee, Michael S; Abraham, Tara S; Baybutt, Trevor R et al. (2018) Human GUCY2C-Targeted Chimeric Antigen Receptor (CAR)-Expressing T Cells Eliminate Colorectal Cancer Metastases. Cancer Immunol Res 6:509-516
Chervoneva, Inna; Freydin, Boris; Hyslop, Terry et al. (2018) Modeling qRT-PCR dynamics with application to cancer biomarker quantification. Stat Methods Med Res 27:2581-2595
Capparelli, Claudia; Purwin, Timothy J; Heilman, Shea A et al. (2018) ErbB3 Targeting Enhances the Effects of MEK Inhibitor in Wild-Type BRAF/NRAS Melanoma. Cancer Res 78:5680-5693
Nevler, Avinoam; Muller, Alexander J; Cozzitorto, Joseph A et al. (2018) A Sub-Type of Familial Pancreatic Cancer: Evidence and Implications of Loss-of-Function Polymorphisms in Indoleamine-2,3-Dioxygenase-2. J Am Coll Surg 226:596-603
Peng, Weidan; Furuuchi, Narumi; Aslanukova, Ludmila et al. (2018) Elevated HuR in Pancreas Promotes a Pancreatitis-Like Inflammatory Microenvironment That Facilitates Tumor Development. Mol Cell Biol 38:
Waldman, Scott A; Camilleri, Michael (2018) Guanylate cyclase-C as a therapeutic target in gastrointestinal disorders. Gut 67:1543-1552
Sullivan-Reed, Katherine; Bolton-Gillespie, Elisabeth; Dasgupta, Yashodhara et al. (2018) Simultaneous Targeting of PARP1 and RAD52 Triggers Dual Synthetic Lethality in BRCA-Deficient Tumor Cells. Cell Rep 23:3127-3136
Lu, Huimin; Bowler, Nicholas; Harshyne, Larry A et al. (2018) Exosomal ?v?6 integrin is required for monocyte M2 polarization in prostate cancer. Matrix Biol 70:20-35

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