The Clinical Trials Office (CTO) provides Protocol and Data Management (CPDM) services to all oncology research projects. The CTO provides infrastructure for oversight and quality control functions, including centralized education and training services for clinical research personnel. The CPDM services are a joint effort between staff in the Cancer Protocol Committee (CPC), clinical trials monitoring team, Safety Oversight Committee (SOC), and DCI Information Technology (IT) shared resource to provide start-to-finish clinical trials services to Cancer Institute members. The PRMS administration by the CPC, quality assurance and research compliance by the monitoring team, data and safety monitoring by the SOC, database development & management by the IT shared resource are all centralized. The CPDM central infrastructure is essential to develop and manage an IT environment that is required to develop databases, and train the users to collect, track, and generate reports for the DCI clinical trial portfolio. This central CPDM approach permits the DCI to assess the DCI clinical trials portfolio, its performance, and its alignment with DCI priorities. It allows the DCI to engage the cancer patient community and recruit potential research subjects by providing information on the DCI website about trials that are open to enrollment. It supports the ability of DCI members to report portfolio metrics in large collaboration-based grant applications such as the CCSG, UM1, NCTN, and various SPORE grants. It enables the PRMS to analyze data on protocol startup and approval times in order to identify gaps in review process efficiency. It also permits the DCI to comply with federally-mandated ClinicalTrials.gov and NCI Clinical Trials Reporting Program (CTRP) requirements. The CPDM facilitates design and development of clinical trials in a 21CFR Part 11 compliant electronic data capture platforms such as Oracle Clinical (C3D) and NCI approved Medidata Rave. All cancer research participants are registered in eResearch database. In the last five years a total of 15,028 adult subjects and 751 pediatric subjects were enrolled in cancer research trials at Duke; 9,681 adult subjects in therapeutic trials and 5,347 adult subjects in non-therapeutic trials. The adult subject enrollment included 8,495 (57%) of women and 2,268 (15%) of African Americans. The CPDM ongoing effort is to enhance the use of technology to efficiently collect, manage and share clinical research information with DCI members, cancer patients, and external collaborators.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA014236-45
Application #
9620048
Study Section
Subcommittee I - Career Development (NCI)
Project Start
Project End
Budget Start
2019-01-01
Budget End
2019-12-31
Support Year
45
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Duke University
Department
Type
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Galaz-Montoya, Monica; Wright, Sara J; Rodriguez, Gustavo J et al. (2017) ?2-Adrenergic receptor activation mobilizes intracellular calcium via a non-canonical cAMP-independent signaling pathway. J Biol Chem 292:9967-9974
Lanier, Megan L; Park, Hyeri; Mukherjee, Paramita et al. (2017) Formal Synthesis of (+)-Laurencin by Gold(I)-Catalyzed Intramolecular Dehydrative Alkoxylation. Chemistry 23:7180-7184
Shi, Qiong; Liu, Hongliang; Han, Peng et al. (2017) Genetic Variants in WNT2B and BTRC Predict Melanoma Survival. J Invest Dermatol 137:1749-1756
Woyach, Jennifer A; Ruppert, Amy S; Guinn, Daphne et al. (2017) BTKC481S-Mediated Resistance to Ibrutinib in Chronic Lymphocytic Leukemia. J Clin Oncol 35:1437-1443
Wang, Yanru; Freedman, Jennifer A; Liu, Hongliang et al. (2017) Associations between RNA splicing regulatory variants of stemness-related genes and racial disparities in susceptibility to prostate cancer. Int J Cancer 141:731-743
Fayanju, Oluwadamilola M; Hall, Carolyn S; Bauldry, Jessica Bowman et al. (2017) Body mass index mediates the prognostic significance of circulating tumor cells in inflammatory breast cancer. Am J Surg 214:666-671
Leu, David; Spasojevic, Ivan; Nguyen, Huy et al. (2017) CNS bioavailability and radiation protection of normal hippocampal neurogenesis by a lipophilic Mn porphyrin-based superoxide dismutase mimic, MnTnBuOE-2-PyP5. Redox Biol 12:864-871
Sauer, Scott J; Tarpley, Michael; Shah, Imran et al. (2017) Bisphenol A activates EGFR and ERK promoting proliferation, tumor spheroid formation and resistance to EGFR pathway inhibition in estrogen receptor-negative inflammatory breast cancer cells. Carcinogenesis 38:252-260
Pan, Yongchu; Liu, Hongliang; Wang, Yanru et al. (2017) Associations between genetic variants in mRNA splicing-related genes and risk of lung cancer: a pathway-based analysis from published GWASs. Sci Rep 7:44634
Yin, Jieyun; Liu, Hongliang; Liu, Zhensheng et al. (2017) Pathway-analysis of published genome-wide association studies of lung cancer: A potential role for the CYP4F3 locus. Mol Carcinog 56:1663-1672

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