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 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; 3. The 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 Boards (DSMB), which are responsible for data and safety monitoring of Kimmel Cancer Center investigator initiated trials (KCC NT). The DSMP requires that every Kimmel Cancer Center protocol include a Data and Safety 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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA056036-13
Application #
8378897
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2012-06-01
Budget End
2013-05-31
Support Year
13
Fiscal Year
2012
Total Cost
$70,719
Indirect Cost
$24,779
Name
Thomas Jefferson University
Department
Type
DUNS #
053284659
City
Philadelphia
State
PA
Country
United States
Zip Code
19107
Mikkilineni, Lekha; Whitaker-Menezes, Diana; Domingo-Vidal, Marina et al. (2017) Hodgkin lymphoma: A complex metabolic ecosystem with glycolytic reprogramming of the tumor microenvironment. Semin Oncol 44:218-225
Wirblich, Christoph; Coleman, Christopher M; Kurup, Drishya et al. (2017) One-Health: a Safe, Efficient, Dual-Use Vaccine for Humans and Animals against Middle East Respiratory Syndrome Coronavirus and Rabies Virus. J Virol 91:
Weinberg, David S; Lin, Jieru E; Foster, Nathan R et al. (2017) Bioactivity of Oral Linaclotide in Human Colorectum for Cancer Chemoprevention. Cancer Prev Res (Phila) 10:345-354
Monti, Daniel; Sotgia, Federica; Whitaker-Menezes, Diana et al. (2017) Pilot study demonstrating metabolic and anti-proliferative effects of in vivo anti-oxidant supplementation with N-Acetylcysteine in Breast Cancer. Semin Oncol 44:226-232
Curry, Joseph; Johnson, Jennifer; Tassone, Patrick et al. (2017) Metformin effects on head and neck squamous carcinoma microenvironment: Window of opportunity trial. Laryngoscope 127:1808-1815
Mitra, Ramkrishna; Chen, Xi; Greenawalt, Evan J et al. (2017) Decoding critical long non-coding RNA in ovarian cancer epithelial-to-mesenchymal transition. Nat Commun 8:1604
Paolillo, Carmela; Mu, Zhaomei; Rossi, Giovanna et al. (2017) Detection of Activating Estrogen Receptor Gene (ESR1) Mutations in Single Circulating Tumor Cells. Clin Cancer Res 23:6086-6093
Overmiller, Andrew M; Pierluissi, Jennifer A; Wermuth, Peter J et al. (2017) Desmoglein 2 modulates extracellular vesicle release from squamous cell carcinoma keratinocytes. FASEB J 31:3412-3424
Cheng, Hanyin; Chua, Vivian; Liao, Connie et al. (2017) Co-targeting HGF/cMET Signaling with MEK Inhibitors in Metastatic Uveal Melanoma. Mol Cancer Ther 16:516-528
Jiang, Wei; Dulaimi, Essel; Devarajan, Karthik et al. (2017) Intratumoral heterogeneity analysis reveals hidden associations between protein expression losses and patient survival in clear cell renal cell carcinoma. Oncotarget 8:37423-37434

Showing the most recent 10 out of 777 publications