The Clinical Trials Office (CTO) provides a centralized and comprehensive infrastructure for the conduct of clinical trials involving cancer patients at Huntsman Cancer Institute (HCI). The CTO has evolved substantially since 2003 to reflect the Cancer Center's commitment to enhancing clinical research and to address the increasingly complex regulatory environment associated with clinical trials. The CTO functions as a central administrative office for the implementation and conduct of internally and externally funded adult oncology studies and integrates with the Pediatric Trials Office located at Primary Children's Medical Center for studies of cancers in children. The goals of the CTO are to 1) support Cancer Center investigators with all aspects of protocol development, initiation, implementation, management, and clinical study coordination;2) prepare and process all regulatory documents for submission to the Institutional Review Board, Protocol Review and Monitoring System (known as the Clinical Cancer Investigations Committee at HCI), Data and Safety Monitoring Committee, Food and Drug Administration (FDA), and other regulatory committees, as required by federal and University of Utah (U of U) policies;3) negotiate budgets and contracts with study sponsors and the U of U Office of Sponsored Projects;4) manage billing and collection of study finances;and 5) provide quality data to regulatory committees and sponsors. The CTO is internally organized into specialty functions: regulatory, finance, and coordination. These groups are assigned to support specific organ-based tumor groups matching the HCI multidisciplinary clinical model. An independent group with a separate reporting structure oversees compliance. The CTO currently employs 35 staff and two faculty involved in study coordination, study compliance, data management, finance, regulation, specimen processing and collection of samples, research nursing, administration, protocol writing, grant development, and investigational new drug filing with the FDA. The CTO Shared Resource is managed by the Cancer Center with supervision by the Clinical Research Executive Committee chaired by Sean Mulvihill, MD, Senior Director of Clinical Affairs. The Funds are requested from the CCSG to cover 4 percent ($109,171) of the proposed CTO Shared Resource budget.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA042014-25
Application #
8661139
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-05-01
Budget End
2015-04-30
Support Year
25
Fiscal Year
2014
Total Cost
$77,764
Indirect Cost
$19,955
Name
University of Utah
Department
Type
DUNS #
009095365
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
Khorashad, J S; Tantravahi, S K; Yan, D et al. (2016) Rapid conversion of chronic myeloid leukemia to chronic myelomonocytic leukemia in a patient on imatinib therapy. Leukemia 30:2275-2279
Flores, Kristina G; Steffen, Laurie E; McLouth, Christopher J et al. (2016) Factors Associated with Interest in Gene-Panel Testing and Risk Communication Preferences in Women from BRCA1/2 Negative Families. J Genet Couns :
Neklason, Deborah W; VanDerslice, James; Curtin, Karen et al. (2016) Evidence for a heritable contribution to neuroendocrine tumors of the small intestine. Endocr Relat Cancer 23:93-100
(2016) PALB2, CHEK2 and ATM rare variants and cancer risk: data from COGS. J Med Genet 53:800-811
Norton, Maria C; Fauth, Elizabeth; Clark, Christine J et al. (2016) Family member deaths across adulthood predict Alzheimer's disease risk: The Cache County Study. Int J Geriatr Psychiatry 31:256-63
Piccolo, Stephen R; Hoffman, Laura M; Conner, Thomas et al. (2016) Integrative analyses reveal signaling pathways underlying familial breast cancer susceptibility. Mol Syst Biol 12:860
Zhu, Judy; Fleming, Aaron M; Orendt, Anita M et al. (2016) pH-Dependent Equilibrium between 5-Guanidinohydantoin and Iminoallantoin Affects Nucleotide Insertion Opposite the DNA Lesion. J Org Chem 81:351-9
Riedl, Jan; Fleming, Aaron M; Burrows, Cynthia J (2016) Sequencing of DNA Lesions Facilitated by Site-Specific Excision via Base Excision Repair DNA Glycosylases Yielding Ligatable Gaps. J Am Chem Soc 138:491-4
Serpico, Victoria; Liepert, Amy E; Boucher, Kenneth et al. (2016) The Effect of Previsit Education in Breast Cancer Patients: A Study of a Shared-decision-making Tool. Am Surg 82:259-65
Camp, Nicola J; Lin, Wei-Yu; Bigelow, Alex et al. (2016) Discordant Haplotype Sequencing Identifies Functional Variants at the 2q33 Breast Cancer Risk Locus. Cancer Res 76:1916-25

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