The Clinical Trials Support Resource (CTSR) provides infrastructure support for all aspects of clinical protocol research at MD Anderson. The services of this shared resource encompass submitting, activating, and closing single and multi-centered clinical trials;educating research staff on human subjects/clinical research;auditing and monitoring active clinical trials;and ensuring regulatory compliance of IND studies. The online data management system is maintained by the CTSR. The CTSR complements the activities of the Protocol Review and Monitoring System by supporting the electronic protocol submission and review processes, and the CTSR will manage the transition from the current electronic protocol management system to a new platform called """"""""eResearch,"""""""" which will """"""""go live"""""""" in early 2013. The CTSR is supported by 106 staff members (of which 8 full-time employees receive full or partial support from the CCSG) under the direction of Dr. Aman Buzdar, Vice President for Clinical Research Administration. During the past 5 years, the number of new protocols managed by CTSR has increased by 4% from 4,632 in fiscal year (FY) 2007 to 4,818 in FY 2011. Overall, trials led by MD Anderson investigators contributed to the FDA approval of 19 drugs for initial or new indications. New patient registrations have increased from 28,762 in FY 2007 to 46,262 in FY 2011, and the number of patients enrolled in therapeutic clinical trials has increased by 18%, from 6,219 in FY 2007 to 7,558 in FY 2011. During the last grant year, the funds used to support the CTSR salaries were $442,190 (9%) from the CCSG, $812,112 (16%) from user fees, and $3,742,322 (75%) from MD Anderson. In the next award cycle, the level of support from the CCSG, user fees, and MD Anderson is projected to be closer to 4%, 7%, and 89%, respectively. During this past 5-year funding period, CTSR resources were used by 934 principal investigators affiliated with all 19 CCSG programs. Peer reviewed investigators account for 61% of the utilization and 4% of total costs are requested from the CCSG. Publications cited using the CTSR have appeared in several high impact journals such as N Engl J Med and J Clin Oncol. Future plans include implementation of eResearch, which will serve as the new institutional clinical data enterprise system;coordination and modification of inter-departmental operational processes to further reduce time from submission to activation of clinical trials to 60 days;and further enhancements to the human subjects protection training programs.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA016672-39
Application #
8759803
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
39
Fiscal Year
2014
Total Cost
$614,509
Indirect Cost
$230,601
Name
University of Texas MD Anderson Cancer Center
Department
Type
DUNS #
800772139
City
Houston
State
TX
Country
United States
Zip Code
77030
Casasent, Anna K; Schalck, Aislyn; Gao, Ruli et al. (2018) Multiclonal Invasion in Breast Tumors Identified by Topographic Single Cell Sequencing. Cell 172:205-217.e12
Noh, Hyangsoon; Zhao, Qingnan; Yan, Jun et al. (2018) Cell surface vimentin-targeted monoclonal antibody 86C increases sensitivity to temozolomide in glioma stem cells. Cancer Lett 433:176-185
Hutcheson, Katherine A; Barrow, Martha P; Plowman, Emily K et al. (2018) Expiratory muscle strength training for radiation-associated aspiration after head and neck cancer: A case series. Laryngoscope 128:1044-1051
Zhao, Jun; Xiao, Zhilan; Li, Tingting et al. (2018) Stromal Modulation Reverses Primary Resistance to Immune Checkpoint Blockade in Pancreatic Cancer. ACS Nano 12:9881-9893
Akhtari, Mani; Milgrom, Sarah A; Pinnix, Chelsea C et al. (2018) Reclassifying patients with early-stage Hodgkin lymphoma based on functional radiographic markers at presentation. Blood 131:84-94
Barua, Souptik; Solis, Luisa; Parra, Edwin Roger et al. (2018) A Functional Spatial Analysis Platform for Discovery of Immunological Interactions Predictive of Low-Grade to High-Grade Transition of Pancreatic Intraductal Papillary Mucinous Neoplasms. Cancer Inform 17:1176935118782880
Ma, Junsheng; Chan, Wenyaw; Tilley, Barbara C (2018) Continuous time Markov chain approaches for analyzing transtheoretical models of health behavioral change: A case study and comparison of model estimations. Stat Methods Med Res 27:593-607
Bayraktar, Recep; Ivan, Cristina; Bayraktar, Emine et al. (2018) Dual Suppressive Effect of miR-34a on the FOXM1/eEF2-Kinase Axis Regulates Triple-Negative Breast Cancer Growth and Invasion. Clin Cancer Res 24:4225-4241
Parra, Edwin R; Villalobos, Pamela; Mino, Barbara et al. (2018) Comparison of Different Antibody Clones for Immunohistochemistry Detection of Programmed Cell Death Ligand 1 (PD-L1) on Non-Small Cell Lung Carcinoma. Appl Immunohistochem Mol Morphol 26:83-93
Yalniz, Fevzi Firat; Daver, Naval; Rezvani, Katayoun et al. (2018) A Pilot Trial of Lirilumab With or Without Azacitidine for Patients With Myelodysplastic Syndrome. Clin Lymphoma Myeloma Leuk 18:658-663.e2

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