? Protocol Review and Monitoring System The Chao Family Comprehensive Cancer Center (CFCCC) Protocol Review and Monitoring System is implemented through the activities of its review committees and is supported and facilitated by administrative staff. The system is designed to increase the translation of CFCCC discoveries from the laboratory into the clinic and improve the efficiency of opening and managing clinical trials. Proposed protocols are brought forward by individual investigators to either a Disease-Oriented Team (DOT) or a corresponding multidisciplinary tumor board. These groups are charged with determining their level of interest in and commitment to the trial, whether the scientific question addressed is of sufficient importance to their field, the appropriateness of the trial design, the potential to accrue to the trial, any conflicts with existing studies and prioritization, and possible correlative translation science that could be captured. The principal charge of the Protocol Review and Monitoring Committee (PRMC) is evaluation of scientific quality and progress. For scientific quality, the PRMC will evaluate only institutional, investigator-initiated trials (IITs) that have not undergone this process elsewhere. Cooperative group and pharmaceutical industry trials, which have been vetted on a national level, are exempt from this review. In addition to scientific quality, the PRMC assesses whether the clinical trials office has the appropriate resources (e.g. data management, pharmacy, nursing, etc.) to support the trial, how the trial fits into the broad interests of the Cancer Center (e.g. portfolio balance across disease areas, potential for accrual of women and minorities, whether the trial is an IIT), and the track record of the principal investigator in accruing to previous trials. The PRMC will continue to routinely review scientific progress for all open trials and also consider data timeliness and quality. The PRMC may disapprove a trial, approve a trial, or request additional information from the PI. The record of deliberations of the PRMC and correspondence with the PI is documented in the clinical trials management system, OnCore.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA062203-23
Application #
9851366
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2020-02-01
Budget End
2021-01-31
Support Year
23
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of California Irvine
Department
Type
DUNS #
046705849
City
Irvine
State
CA
Country
United States
Zip Code
92617
Mahlbacher, Grace; Curtis, Louis T; Lowengrub, John et al. (2018) Mathematical modeling of tumor-associated macrophage interactions with the cancer microenvironment. J Immunother Cancer 6:10
Neek, Medea; Tucker, Jo Anne; Kim, Tae Il et al. (2018) Co-delivery of human cancer-testis antigens with adjuvant in protein nanoparticles induces higher cell-mediated immune responses. Biomaterials 156:194-203
McLelland, Bryce T; Lin, Bin; Mathur, Anuradha et al. (2018) Transplanted hESC-Derived Retina Organoid Sheets Differentiate, Integrate, and Improve Visual Function in Retinal Degenerate Rats. Invest Ophthalmol Vis Sci 59:2586-2603
Bota, Daniela A; Chung, Jinah; Dandekar, Manisha et al. (2018) Phase II study of ERC1671 plus bevacizumab versus bevacizumab plus placebo in recurrent glioblastoma: interim results and correlations with CD4+ T-lymphocyte counts. CNS Oncol 7:CNS22
Han, Han; Qi, Ruxi; Zhou, Jeff Jiajing et al. (2018) Regulation of the Hippo Pathway by Phosphatidic Acid-Mediated Lipid-Protein Interaction. Mol Cell 72:328-340.e8
Solares, Edwin A; Chakraborty, Mahul; Miller, Danny E et al. (2018) Rapid Low-Cost Assembly of the Drosophila melanogaster Reference Genome Using Low-Coverage, Long-Read Sequencing. G3 (Bethesda) 8:3143-3154
Wang, Yajun; Ngor, Arlene K; Nikoomanzar, Ali et al. (2018) Evolution of a General RNA-Cleaving FANA Enzyme. Nat Commun 9:5067
Qiu, Xiaolong; Lombardo, Jeremy A; Westerhof, Trisha M et al. (2018) Microfluidic filter device with nylon mesh membranes efficiently dissociates cell aggregates and digested tissue into single cells. Lab Chip 18:2776-2786
Patterson, Kurt; Yu, James; Landberg, Jenny et al. (2018) Functional genomics for the oleaginous yeast Yarrowia lipolytica. Metab Eng 48:184-196
Lee, J Scott; Roberts, Andrew; Juarez, Dennis et al. (2018) Statins enhance efficacy of venetoclax in blood cancers. Sci Transl Med 10:

Showing the most recent 10 out of 1106 publications