- Clinical Protocol and Data Management (CPDM) The Clinical Protocol and Data Management component includes the Clinical Protocol Office (CPO), the clinical data management team, and the compliance committees (Audit; Data and Safety Monitoring). These integrated groups provide centralized management and oversight for cancer clinical trials conducted by members of the UNC Lineberger Comprehensive Cancer Center (LCCC). The CPDM delivers a full range of management and quality control services for investigator-initiated local and multi-center trials (IITs), industry or other sponsored trials, as well as those originating in the National Clinical Trials Network groups and the Experimental Therapeutics Clinical Trials Network. The CPO centralizes the protocol registration, regulatory affairs, compliance committee work, management of clinical trials, and facilitates efficient and effective training for research personnel and timely activation of protocols in support of cancer center investigators from all relevant disciplines. Investigator-initiated protocol development is facilitated by dedicated specialists who work with investigators. Claire Dees serves as Medical Director of the CPO and chairs the Protocol Office Executive Committee, which is comprised of the disease-specific Protocol Office Disease Group faculty leaders. Carrie Lee and Jared Weiss provide additional faculty leadership with responsibility for operations and finance. The accrual to all intervention trials at UNC in 2014 was 1731 patients. Accrual to treatment interventions at UNC was 604 cancer patients. Observational studies enrolled 4790 subjects and 572 were accrued to ancillary or correlative trials at UNC. The total UNC accrual to studies of all types was 7093 subjects. Affiliate sites accrued 450 subjects to UNC IITs. The CPDM audits investigator-initiated and NCI-funded therapeutic trials to authenticate compliance and capture of accurate data through its Audit Subcommittee. The Audit Subcommittee meets following the monthly audit to review findings from the audit. Audit findings are addressed directly to the Principal Investigator, with a summary being issued to the Principal Investigator and the Protocol Review Committee. The Data Safety and Monitoring Committee reviews trials on a regular (quarterly to annually) basis, with the frequency of review based on risk and complexity as determined by the LCCC Protocol Review Committee. The UNC Lineberger conducts research on minority health disparities and continually seeks new ways to optimize accrual of women and minorities to trials. Dr. Wendy Brewster serves as Faculty Advisor for Minority Accrual. Initiatives to facilitate minority accrual include a dedicated interpreter and modification of our clinical trial prioritization checklist to specify minority and female target accrual, which will generate information needed to identify obstacles to accrual. We are also exploring options to use Epic as a way to monitor accrual rates by cancer division and the individual oncologist and remind physicians about relevant trials.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA016086-44
Application #
9834866
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2019-12-01
Budget End
2020-11-30
Support Year
44
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Type
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Shen, Hui; Shih, Juliann; Hollern, Daniel P et al. (2018) Integrated Molecular Characterization of Testicular Germ Cell Tumors. Cell Rep 23:3392-3406
Shao, Wenwei; Chen, Xiaojing; Samulski, Richard J et al. (2018) Inhibition of antigen presentation during AAV gene therapy using virus peptides. Hum Mol Genet 27:601-613
Gao, Yanzhe; Kardos, Jordan; Yang, Yang et al. (2018) The Cancer/Testes (CT) Antigen HORMAD1 promotes Homologous Recombinational DNA Repair and Radioresistance in Lung adenocarcinoma cells. Sci Rep 8:15304
Schaefer, Kristina N; Bonello, Teresa T; Zhang, Shiping et al. (2018) Supramolecular assembly of the beta-catenin destruction complex and the effect of Wnt signaling on its localization, molecular size, and activity in vivo. PLoS Genet 14:e1007339
Zuze, Takondwa; Painschab, Matthew S; Seguin, Ryan et al. (2018) Plasmablastic lymphoma in Malawi. Infect Agent Cancer 13:22
Wang, Jeremy R; Holt, James; McMillan, Leonard et al. (2018) FMLRC: Hybrid long read error correction using an FM-index. BMC Bioinformatics 19:50
Lee, Janie M; Abraham, Linn; Lam, Diana L et al. (2018) Cumulative Risk Distribution for Interval Invasive Second Breast Cancers After Negative Surveillance Mammography. J Clin Oncol 36:2070-2077
Thomas, Nancy E; Edmiston, Sharon N; Orlow, Irene et al. (2018) Inherited Genetic Variants Associated with Melanoma BRAF/NRAS Subtypes. J Invest Dermatol 138:2398-2404
Cousins, Emily M; Goldfarb, Dennis; Yan, Feng et al. (2018) Competitive Kinase Enrichment Proteomics Reveals that Abemaciclib Inhibits GSK3? and Activates WNT Signaling. Mol Cancer Res 16:333-344
Armstrong, Robin L; Penke, Taylor J R; Strahl, Brian D et al. (2018) Chromatin conformation and transcriptional activity are permissive regulators of DNA replication initiation in Drosophila. Genome Res 28:1688-1700

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