The Clinical Trials Shared Resource (CTSR) is pivotal to the conduct of clinical research within the Duke Comprehensive Cancer Institute. This resource has evolved over the past 20 years from an embryonic oneperson protocol office to Its current staff of 16, centralizing protocol development, Protocol Review and Mooitoring-S-ystem-(HRMS)-admlni$tfation,-the Clinical-Trials-Quality-Assurance-and -Education-Program r and the Duke Comprehensive Cancer Institute (DCCI) Clinical Trials Office. The DCCI Clinical Trials Office Is a full-service operation offering start-to-finish clinical trials services to Cancer Institute members. The administrafive functions (protocol administration, PRMS administrafion, E-research database of protocols, pafient registrafion, quality assurance, safety surveillance desk and educafion of the CTSR stafl) are all centralized. All DCCl protocols, regardless of sponsorship, are processed through the CTSR Office for review by the PRMS and abstracted into the central database (E-research). All DCCI protocol subjects are registered through the CTSR Office and the disease site clusters for entry in E-research (average annual total accrual based on last five years: 5659 patients on therapeutic trials;14,420 subjects on non-therapeutic trials). Personnel providing start-up services are also housed in the CTSR Office. The Core Monitoring Team is staffed by members of the CTSR Office. Clinical trials operations are organized into disease and modalityspecific teams of Clinical Research Nurses (CRNs) and data managers (CRAs). The current teams, with total staffing over 100, are aligned with the existing programs of Breast and Ovarian Oncology, Experimental Therapeufics, Cancer Immunobiology, and Radiafion Oncology. The goal of the CTSR is to align its services in support ofthe scientific priorities ofthe Duke Comprehensive Cancer Insfitute. The CTSR is used mostly by peer-reviewed, DCCI members with highest priority given to peer-reviewed research. Charge-backs are on a sliding scale, with the biggest discounts provided to DCCl members conducfing peer-reviewed research.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Duke University
United States
Zip Code
Adams, Rebecca N; Mosher, Catherine E; Blair, Cindy K et al. (2015) Cancer survivors' uptake and adherence in diet and exercise intervention trials: an integrative data analysis. Cancer 121:77-83
Pruszynski, Marek; Koumarianou, Eftychia; Vaidyanathan, Ganesan et al. (2014) Improved tumor targeting of anti-HER2 nanobody through N-succinimidyl 4-guanidinomethyl-3-iodobenzoate radiolabeling. J Nucl Med 55:650-6
Batinic-Haberle, Ines; Tovmasyan, Artak; Roberts, Emily R H et al. (2014) SOD therapeutics: latest insights into their structure-activity relationships and impact on the cellular redox-based signaling pathways. Antioxid Redox Signal 20:2372-415
Sachdeva, Mohit; Mito, Jeffrey K; Lee, Chang-Lung et al. (2014) MicroRNA-182 drives metastasis of primary sarcomas by targeting multiple genes. J Clin Invest 124:4305-19
Tovmasyan, Artak; Carballal, Sebastian; Ghazaryan, Robert et al. (2014) Rational design of superoxide dismutase (SOD) mimics: the evaluation of the therapeutic potential of new cationic Mn porphyrins with linear and cyclic substituents. Inorg Chem 53:11467-83
Azrad, Maria; Demark-Wahnefried, Wendy (2014) The association between adiposity and breast cancer recurrence and survival: A review of the recent literature. Curr Nutr Rep 3:9-15
Blair, Cindy K; Madan-Swain, Avi; Locher, Julie L et al. (2013) Harvest for health gardening intervention feasibility study in cancer survivors. Acta Oncol 52:1110-8
Mito, Jeffrey K; Min, Hooney D; Ma, Yan et al. (2013) Oncogene-dependent control of miRNA biogenesis and metastatic progression in a model of undifferentiated pleomorphic sarcoma. J Pathol 229:132-40
Pruszynski, Marek; Koumarianou, Eftychia; Vaidyanathan, Ganesan et al. (2013) Targeting breast carcinoma with radioiodinated anti-HER2 Nanobody. Nucl Med Biol 40:52-9
Hover, Bradley M; Loksztejn, Anna; Ribeiro, Anthony A et al. (2013) Identification of a cyclic nucleotide as a cryptic intermediate in molybdenum cofactor biosynthesis. J Am Chem Soc 135:7019-32

Showing the most recent 10 out of 161 publications