9.2 Clinical Trials Protocol Review &Monitoring Committee 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 industrysponsored 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.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of California Irvine
United States
Zip Code
Charney, Rebekah M; Forouzmand, Elmira; Cho, Jin Sun et al. (2017) Foxh1 Occupies cis-Regulatory Modules Prior to Dynamic Transcription Factor Interactions Controlling the Mesendoderm Gene Program. Dev Cell 40:595-607.e4
HD iPSC Consortium (2017) Developmental alterations in Huntington's disease neural cells and pharmacological rescue in cells and mice. Nat Neurosci 20:648-660
McCracken, A N; McMonigle, R J; Tessier, J et al. (2017) Phosphorylation of a constrained azacyclic FTY720 analog enhances anti-leukemic activity without inducing S1P receptor activation. Leukemia 31:669-677
Barton, James C; Chen, Wen-Pin; Emond, Mary J et al. (2017) GNPAT p.D519G is independently associated with markedly increased iron stores in HFE p.C282Y homozygotes. Blood Cells Mol Dis 63:15-20
Yan, Huaming; Romero-Lopez, Monica; Frieboes, Hermann B et al. (2017) Multiscale Modeling of Glioblastoma Suggests that the Partial Disruption of Vessel/Cancer Stem Cell Crosstalk Can Promote Tumor Regression Without Increasing Invasiveness. IEEE Trans Biomed Eng 64:538-548
Klempner, Samuel J; Mehta, Pareen; Schrock, Alexa B et al. (2017) Cis-oriented solvent-front EGFR G796S mutation in tissue and ctDNA in a patient progressing on osimertinib: a case report and review of the literature. Lung Cancer (Auckl) 8:241-247
Molino, Nicholas M; Neek, Medea; Tucker, Jo Anne et al. (2017) Display of DNA on Nanoparticles for Targeting Antigen Presenting Cells. ACS Biomater Sci Eng 3:496-501
Lomeli, Naomi; Di, Kaijun; Czerniawski, Jennifer et al. (2017) Cisplatin-induced mitochondrial dysfunction is associated with impaired cognitive function in rats. Free Radic Biol Med 102:274-286
Huang, Jason Y; Samarasena, Jason B; Tsujino, Takeshi et al. (2017) EUS-guided portal pressure gradient measurement with a simple novel device: a human pilot study. Gastrointest Endosc 85:996-1001
Elbir, Haitham; Sitlani, Parth; Bergström, Sven et al. (2017) Chromosome and Megaplasmid Sequences of Borrelia anserina (Sakharoff 1891), the Agent of Avian Spirochetosis and Type Species of the Genus. Genome Announc 5:

Showing the most recent 10 out of 1031 publications