Core B will provide comprehensive and centralized support that integrates the biostatistical activities and data management for the clinical trials and laboratory projects proposed by investigators from the MD Anderson Cancer Center (MDACC), Baylor College of Medicine (BCM) and the University of Texas Institute of Molecular Medicine (IMM). Core Director, Dr. Donald A. Berry, and the Co-Director, Dr. Hao Liu, will coordinate the biostatistical support using a centralized web-based data management system. Core activities will be a team effort, with every member contributing his/her area of specialization. Team members from MDACC and BCM have substantial experience in collaborative activities. Explicit issues addressed in this Core include statistical study design, data analysis and data management. Core B provides statistical support for all projects, including the related data management and computing components.
The specific aims of Core B are to: 1) coordinate and manage the statistical activities to ensure that investigators have ready and dedicated access to biostatistical consultation, 2) provide statistical design, planning, and conduct of clinical trials and preclinical validation, 3) provide comprehensive support for data analysis including futility/safety/toxicity monitoring, interim reviews of data, final analysis, interpretation and reporting, and 4) coordinate data management activities in close collaboration with the Administrative Core. In addition, Core B will support the bi-institutional clinical trials (MDACC and BCM only) of all Projects by providing computing facilities and resources for research requirements and by implementing patient-specific data management. This includes data review, transfer, sharing, and security as well as quality control and protocol compliance. This Core will provide biostatistical support to all four research Projects. Centralized biostatistical support will ensure that biostatisticians are familiar with the unique as well as the interrelated aspects of each Project and provide and infrastructure for interactions among biostatisticians and investigators. Consequently, this will 1) facilitate efficient use of biostatistical services, 2) provide an opportunity for dynamic collaboration between biostatisticians and investigators in the design, conduct, and interpretation of data resulting from the Projects, and 3) ensure the conduct of high-quality projects in a tri-institutional environment. The Core personnel are highly experienced biostatisticians who are members of the Biostatistics Shared Resources of MDACC and the Dan L. Duncan Cancer Center at BCM.

Public Health Relevance

The implementation and development of statistical designs and analytic tools are critical to the success of the Program Project, where novel statistical input is required. The Core will provide comprehensive and centralized statistical activities for preclinical studies and clinical trials, with the support of a centralized web-based data management system. The iterative approach for preclinical and clinical studies in the Program Project requires effective interaction and collaboration between the statisticians and the research PIs. Experienced statisticians from BCM and MDACC can bring substantial team effort to the projects.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Program Projects (P01)
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Special Emphasis Panel (ZCA1-RPRB-J)
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University of Texas MD Anderson Cancer Center
United States
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Cruz, Conrad R Y; Bollard, Catherine M (2017) Adoptive Immunotherapy For Leukemia With Ex vivo Expanded T Cells. Curr Drug Targets 18:271-280
Kerros, Celine; Tripathi, Satyendra C; Zha, Dongxing et al. (2017) Neuropilin-1 mediates neutrophil elastase uptake and cross-presentation in breast cancer cells. J Biol Chem 292:10295-10305
Kolonin, Mikhail G; Sergeeva, Anna; Staquicini, Daniela I et al. (2017) Interaction between Tumor Cell Surface Receptor RAGE and Proteinase 3 Mediates Prostate Cancer Metastasis to Bone. Cancer Res 77:3144-3150
Alsuliman, Abdullah; Muftuoglu, Muharrem; Khoder, Ahmad et al. (2017) A subset of virus-specific CD161+ T cells selectively express the multidrug transporter MDR1 and are resistant to chemotherapy in AML. Blood 129:740-758
Peters, Haley L; Tripathi, Satyendra C; Kerros, Celine et al. (2017) Serine Proteases Enhance Immunogenic Antigen Presentation on Lung Cancer Cells. Cancer Immunol Res 5:319-329
Houghtelin, Amy; Bollard, Catherine M (2017) Virus-Specific T Cells for the Immunocompromised Patient. Front Immunol 8:1272
Robinson, Simon N; Thomas, Michael W; Simmons, Paul J et al. (2017) Non-fucosylated CB CD34+ cells represent a good target for enforced fucosylation to improve engraftment following cord blood transplantation. Cytotherapy 19:285-292
Dave, Hema; Luo, Min; Blaney, J W et al. (2017) Toward a Rapid Production of Multivirus-Specific T Cells Targeting BKV, Adenovirus, CMV, and EBV from Umbilical Cord Blood. Mol Ther Methods Clin Dev 5:13-21
Naik, Swati; Nicholas, Sarah K; Martinez, Caridad A et al. (2016) Adoptive immunotherapy for primary immunodeficiency disorders with virus-specific T lymphocytes. J Allergy Clin Immunol 137:1498-1505.e1
Nesher, Lior; Shah, Dimpy P; Ariza-Heredia, Ella J et al. (2016) Utility of the Enzyme-Linked Immunospot Interferon-?-Release Assay to Predict the Risk of Cytomegalovirus Infection in Hematopoietic Cell Transplant Recipients. J Infect Dis 213:1701-7

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