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
Cox-Muranami, Wesley A; Nelson, Edward L; Li, G P et al. (2016) Large area magnetic micropallet arrays for cell colony sorting. Lab Chip 16:172-81
Klempner, Samuel J; Gershenhorn, Bruce; Tran, Phu et al. (2016) BRAFV600E Mutations in High-Grade Colorectal Neuroendocrine Tumors May Predict Responsiveness to BRAF-MEK Combination Therapy. Cancer Discov 6:594-600
Li, N; Pasricha, S; Bulsiewicz, W J et al. (2016) Effects of preceding endoscopic mucosal resection on the efficacy and safety of radiofrequency ablation for treatment of Barrett's esophagus: results from the United States Radiofrequency Ablation Registry. Dis Esophagus 29:537-43
Nolen, Shantell C; Lee, Brian; Shantharam, Shruti et al. (2016) The effects of sequential treatments on hippocampal volumes in malignant glioma patients. J Neurooncol 129:433-41
Bota, Daniela A; Davies, Kelvin J A (2016) Mitochondrial Lon protease in human disease and aging: Including an etiologic classification of Lon-related diseases and disorders. Free Radic Biol Med 100:188-198
Pedram, Ali; Razandi, Mahnaz; Blumberg, Bruce et al. (2016) Membrane and nuclear estrogen receptor α collaborate to suppress adipogenesis but not triglyceride content. FASEB J 30:230-40
Greene, Christina L; Worrell, Stephanie G; Attwood, Stephen E et al. (2016) Emerging Concepts for the Endoscopic Management of Superficial Esophageal Adenocarcinoma. J Gastrointest Surg 20:851-60
Iyer, Neel S; Osann, Kathryn; Hsieh, Susie et al. (2016) Health Behaviors in Cervical Cancer Survivors and Associations with Quality of Life. Clin Ther 38:467-75
Leproux, Anaïs; Kim, You Me; Min, Jun Won et al. (2016) Differential diagnosis of breast masses in South Korean premenopausal women using diffuse optical spectroscopic imaging. J Biomed Opt 21:74001
McLaren, Christine E; Barton, James C; Subramaniam, V Nathan et al. (2016) Reply. Hepatology 63:2058-60

Showing the most recent 10 out of 882 publications