As part of our NCI designation, the Chao Family Comprehensive Cancer Center's (CFCCC) Clinical Trials Protocol Review &Monitoring Committee (CTPRMC) serves as the primary Protocol Review and Monitoring System (PRMS). The CTPRMC reviews trials for scientific merit, adequacy of study design, and biostatistical concerns. The Committee also monitors trial accrual on an ongoing basis. The CTPRMC membership reflects the expertise required for the scientific review of trials and consists of CFCCC members and other faculty and staff from diverse fields necessary for complete review of investigator-initiated and pharmaceutical company sponsored trials. Currently, all studies involving cancer patients, including investigator-initiated protocols and industry sponsored trials, must undergo review by the CTPRMC prior to submission to, and review by, the Institutional Review Board (IRB). Studies that do not involve an intervention, such as observational, registry, specimen repository, and retrospective chart reviews studies, may qualify for CTPRMC exemption, as determined by the Director of the Clinical Research Office. In addition, cooperative group trials are exempt from initial review by the CTPRMC if they have received prior peer review by both the cooperative groups and the Clinical Trial Evaluation Program (CTEP). However, monitoring accrual for these trials remains a CTPRMC obligation. Prioritization of these trials is determined by the disease-specific groups at the CFCCC, supervised by the Associate Director for Clinical Research of the CFCCC. The CTPRMC meets twice monthly (alternating full Committee and sub-Committee), to review the essential protocol elements, including clear rationale, appropriate and efficient study design, biostatistical input, attainable accrual, and feasibility for completion within a reasonable time frame.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA062203-18
Application #
8740853
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-09-11
Project End
2014-01-31
Budget Start
2013-02-01
Budget End
2014-01-31
Support Year
18
Fiscal Year
2013
Total Cost
$52,953
Indirect Cost
$18,299
Name
University of California Irvine
Department
Type
DUNS #
046705849
City
Irvine
State
CA
Country
United States
Zip Code
92697
Rush, Christina L; Darling, Margaret; Elliott, Maria Gloria et al. (2015) Engaging Latina cancer survivors, their caregivers, and community partners in a randomized controlled trial: Nueva Vida intervention. Qual Life Res 24:1107-18
Parihar, Vipan K; Allen, Barrett D; Tran, Katherine K et al. (2015) Targeted overexpression of mitochondrial catalase prevents radiation-induced cognitive dysfunction. Antioxid Redox Signal 22:78-91
Stockler, Martin R; Hilpert, Felix; Friedlander, Michael et al. (2014) Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol 32:1309-16
Sun, Peng; Watanabe, Kazuhide; Fallahi, Magid et al. (2014) Pygo2 regulates ?-catenin-induced activation of hair follicle stem/progenitor cells and skin hyperplasia. Proc Natl Acad Sci U S A 111:10215-20
Lackford, Brad; Yao, Chengguo; Charles, Georgette M et al. (2014) Fip1 regulates mRNA alternative polyadenylation to promote stem cell self-renewal. EMBO J 33:878-89
Balu, Mihaela; Kelly, Kristen M; Zachary, Christopher B et al. (2014) Distinguishing between benign and malignant melanocytic nevi by in vivo multiphoton microscopy. Cancer Res 74:2688-97
Yonova, Ivelina M; Osborne, Charlotte A; Morrissette, Naomi S et al. (2014) Diaryl and heteroaryl sulfides: synthesis via sulfenyl chlorides and evaluation as selective anti-breast-cancer agents. J Org Chem 79:1947-53
Watanabe, K; Fallahi, M; Dai, X (2014) Chromatin effector Pygo2 regulates mammary tumor initiation and heterogeneity in MMTV-Wnt1 mice. Oncogene 33:632-42
Kim, Monica Y; Li, David Jiang; Pham, Long K et al. (2014) Microfabrication of High-Resolution Porous Membranes for Cell Culture. J Memb Sci 452:460-469
Cheng, Chunmei; Pal, Sukumar; Tifrea, Delia et al. (2014) A vaccine formulated with a combination of TLR-2 and TLR-9 adjuvants and the recombinant major outer membrane protein elicits a robust immune response and significant protection against a Chlamydia muridarum challenge. Microbes Infect 16:244-52

Showing the most recent 10 out of 289 publications