Abstract

The Protocol Review and Monitoring System (PRMS) ofthe University of California Davis Cancer Center (UCDCC) provides a mechanism for ensuring internal oversight ofthe scientific and research aspects of cancer clinical trials and for assuring that the UCDCC's clinical resources are engaged in the most optimal way. A key element of the PRMS is the Scientific Review Committee (SRC) which provides internal peer review and approval of new treatment and prevention research trials prior to submission to the Institutional Review Board (IRB), which focuses on the protection of human subjects. SRC provides essential review elements for scientific merit, prioritization, resource allocation and accrual monitoring. The PRMS is intended to cover clinical research activity meeting the NCI definition of a clinical trial, as defined in the Data and Safety Monitoring Plan (DSMP) of this application (described further in a separate narrative).

Public Health Relevance

The UCDCC has a system in place that ensures internal oversight of clinical trials. The SRC reviews the scientific aspects and prioritization of clinical trial protocols (before IRB review) and ensures the continued scientific merit of trials once they have been initiated.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA093373-11
Application #
8741029
Study Section
Subcommittee G - Education (NCI)
Project Start
2002-07-01
Project End
2016-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
11
Fiscal Year
2013
Total Cost
$108,448
Indirect Cost
$37,805

  Institution

Name
University of California Davis
Department
Type
DUNS #
047120084
City
Davis
State
CA
Country
United States
Zip Code
95618

  Publications

Braithwaite, Dejana; Miglioretti, Diana L; Zhu, Weiwei et al. (2018) Family History and Breast Cancer Risk Among Older Women in the Breast Cancer Surveillance Consortium Cohort. JAMA Intern Med 178:494-501
Unger, Jakob; Sun, Tianchen; Chen, Yi-Ling et al. (2018) Method for accurate registration of tissue autofluorescence imaging data with corresponding histology: a means for enhanced tumor margin assessment. J Biomed Opt 23:1-11
Wang, Guobao; Corwin, Michael T; Olson, Kristin A et al. (2018) Dynamic PET of human liver inflammation: impact of kinetic modeling with optimization-derived dual-blood input function. Phys Med Biol 63:155004
Winer, Rachel L; Tiro, Jasmin A; Miglioretti, Diana L et al. (2018) Rationale and design of the HOME trial: A pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake and effectiveness in a U.S. healthcare system. Contemp Clin Trials 64:77-87
Withers, Sita S; Skorupski, Katherine A; York, Daniel et al. (2018) Association of macrophage and lymphocyte infiltration with outcome in canine osteosarcoma. Vet Comp Oncol :
Floc'h, Nicolas; Martin, Matthew J; Riess, Jonathan W et al. (2018) Antitumor Activity of Osimertinib, an Irreversible Mutant-Selective EGFR Tyrosine Kinase Inhibitor, in NSCLC Harboring EGFR Exon 20 Insertions. Mol Cancer Ther 17:885-896
Shih, Tsung-Chieh; Liu, Ruiwu; Wu, Chun-Te et al. (2018) Targeting Galectin-1 Impairs Castration-Resistant Prostate Cancer Progression and Invasion. Clin Cancer Res 24:4319-4331
Weiss, Robert H (2018) Metabolomics and Metabolic Reprogramming in Kidney Cancer. Semin Nephrol 38:175-182
Hegde, John V; Shaverdian, Narek; Daly, Megan E et al. (2018) Patient-reported quality-of-life outcomes after de-escalated chemoradiation for human papillomavirus-positive oropharyngeal carcinoma: Findings from a phase 2 trial. Cancer 124:521-529
Arun, Adith S; Tepper, Clifford G; Lam, Kit S (2018) Identification of integrin drug targets for 17 solid tumor types. Oncotarget 9:30146-30162

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