The NCI mandates that all CCSG-funded cancer centers establish a protocol review and monitoring system for oversight of the clinical research conducted at that institution. At the USC Norris Comprehensive Cancer Center (NCCC), the Clinical Investigations Committee (CIC) has this responsibility. The CIC performs the scientific review of proposed cancer clinical studies, and oversees the conduct of all clinical studies open at the NCCC. To facilitate the oversight of open trials, the internal Data and Safety Monitoring Committee (DSMC) will meet monthly to review institutional clinical trials (i.e., cancer-related trials involving an intervention where a USC investigator is the overall principal investigator (PI) of the study and the trial is not part of a national cooperative group or the CCCP Consortium, or sponsored by a pharmaceutical company that will responsible for the data management and oversight of the progress of the trial). Each in-house trial will be reviewed annually or more frequently as determined by the CIC. The reviews of the DSMC complement those of the QAMC, a long-standing Cancer Center committee which is charged with (among other responsibilities) reviewing accrual, and SAE's and major violations in a timely fashion, for all open protocols, as well as conducting audits of patients on institutional clinical trials. The DSMC will work in close coordination with the Clinical Investigations Support Office, which plays the main role of coordinating the conduct of clinical research in the NCCC. The objectives of the DSMC are to: 1. review, at established intervals, safety and aspects of the protocol and study conduct that may impact on safety of current or future patients 2. review all serious adverse events or other adverse events that require expedited reporting 3. review the progress of the study 4. review efficacy results that trigger early closure or early reporting 5. review the completeness and the quality of the research data 6. report the results of each review and make recommendations to the study PI, IRB, the Quality Assurance Monitoring Committee and the CIC.

Public Health Relevance

It is the responsibility of the NCCC to ensure that the trials undertaken at the Cancer Center are scientifically sound and conducted in a rigorous fashion so as to yield timely and meaningful data in order to advance the development of effective diagnostics and treatments. The DSMC will monitor the safety of NCCC institutional trials to ensure patient safety and timely study completion with high quality results.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
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Subcommittee G - Education (NCI)
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University of Southern California
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Schaal, Justin B; Maretzky, Thorsten; Tran, Dat Q et al. (2018) Macrocyclic ?-defensins suppress tumor necrosis factor-? (TNF-?) shedding by inhibition of TNF-?-converting enzyme. J Biol Chem 293:2725-2734
Iriondo, Oihana; Liu, Yarong; Lee, Grace et al. (2018) TAK1 mediates microenvironment-triggered autocrine signals and promotes triple-negative breast cancer lung metastasis. Nat Commun 9:1994
Robison, Nathan J; Yeo, Kee Kiat; Berliner, Adrian P et al. (2018) Phase I trial of dasatinib, lenalidomide, and temozolomide in children with relapsed or refractory central nervous system tumors. J Neurooncol 138:199-207
Naseem, Madiha; Barzi, Afsaneh; Brezden-Masley, Christine et al. (2018) Outlooks on Epstein-Barr virus associated gastric cancer. Cancer Treat Rev 66:15-22
Peres, Lauren C; Risch, Harvey; Terry, Kathryn L et al. (2018) Racial/ethnic differences in the epidemiology of ovarian cancer: a pooled analysis of 12 case-control studies. Int J Epidemiol 47:460-472
Sebio, A; Stintzing, S; Heinemann, V et al. (2018) A genetic variant in Rassf1a predicts outcome in mCRC patients treated with cetuximab plus chemotherapy: results from FIRE-3 and JACCRO 05 and 06 trials. Pharmacogenomics J 18:43-48
Guo, Hao; Lee, Changrim; Shah, Mihir et al. (2018) A novel elastin-like polypeptide drug carrier for cyclosporine A improves tear flow in a mouse model of Sjögren's syndrome. J Control Release 292:183-195
Peddi, Santosh; Pan, Xiaoli; MacKay, John Andrew (2018) Intracellular Delivery of Rapamycin From FKBP Elastin-Like Polypeptides Is Consistent With Macropinocytosis. Front Pharmacol 9:1184
Kahn, Michael (2018) Wnt Signaling in Stem Cells and Cancer Stem Cells: A Tale of Two Coactivators. Prog Mol Biol Transl Sci 153:209-244
Zhao, Yi; Wu, Kaijin; Wu, Yongfeng et al. (2018) Characterization of Imatinib Resistant CML Leukemic Stem/Initiating Cells and Their Sensitivity to CBP/Catenin Antagonists. Curr Mol Pharmacol 11:113-121

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