The Biostatistics Core (Core B) will provide biostatistical expertise in the design, conduct and analysis of the clinical trials, animal studies and related research projects generated under this proposal. The goals of the Core are to provide biostatistical support to the six projects at all phases of the research. Core staff will consult with investigators prior to the initiation of studies to review study objectives and assist in selecting efficient designs and sample sizes that will provide adequate power to address the objectives. For clinical studies, a Core member will conduct a protocol review with investigators and assist in protocol development, sample size determination, plans for interim analyses, and if applicable, randomization. Core staff will perform statistical analyses and data exploration for POI investigators using appropriate statistical methodologies;prepare reports of results;assist with the preparation of presentations and writing of statistical components of manuscripts;and consult on the design of subsequent research. The Core director has widespread experience in applied and methodologic statistical research, which will allow for the most appropriate methodologies to be utilized as well as for modification or development of new methods if needed.

Public Health Relevance

The Biostatistics Core is essential to the design, ongoing review and final analysis of preclinical experiments and clinical trials to translate biological questions into experimentally testable hypotheses yielding interpretable results and to insure that planned clinical trials are feasible, invoke appropriate design and stopping rules to insure safety and are appropriately analyzed and interpreted.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Program Projects (P01)
Project #
5P01CA023766-35
Application #
8739767
Study Section
Special Emphasis Panel (ZCA1)
Project Start
Project End
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
35
Fiscal Year
2014
Total Cost
Indirect Cost
City
New York
State
NY
Country
United States
Zip Code
Ataie, Niloufar; Xiang, Jingyi; Cheng, Neal et al. (2016) Structure of a TCR-Mimic Antibody with Target Predicts Pharmacogenetics. J Mol Biol 428:194-205
Richardson, Paul G; Riches, Marcie L; Kernan, Nancy A et al. (2016) Phase 3 trial of defibrotide for the treatment of severe veno-occlusive disease and multi-organ failure. Blood 127:1656-65
Hasan, A N; Selvakumar, A; Shabrova, E et al. (2016) Soluble and membrane-bound interleukin (IL)-15 Rα/IL-15 complexes mediate proliferation of high-avidity central memory CD8(+) T cells for adoptive immunotherapy of cancer and infections. Clin Exp Immunol 186:249-265
Spitzer, Barbara; Perales, Miguel-Angel; Kernan, Nancy A et al. (2016) Second Allogeneic Stem Cell Transplantation for Acute Leukemia Using a Chemotherapy-Only Cytoreduction with Clofarabine, Melphalan, and Thiotepa. Biol Blood Marrow Transplant 22:1449-54
Park, Jae H; Geyer, Mark B; Brentjens, Renier J (2016) CD19-targeted CAR T-cell therapeutics for hematologic malignancies: interpreting clinical outcomes to date. Blood 127:3312-20
Xiong, Huizhong; Keith, James W; Samilo, Dane W et al. (2016) Innate Lymphocyte/Ly6C(hi) Monocyte Crosstalk Promotes Klebsiella Pneumoniae Clearance. Cell 165:679-89
Jiang, Yanwen; Ortega-Molina, Ana; Geng, Huimin et al. (2016) CREBBP Inactivation Promotes the Development of HDAC3 Dependent Lymphomas. Cancer Discov :
Shono, Yusuke; Docampo, Melissa D; Peled, Jonathan U et al. (2016) Increased GVHD-related mortality with broad-spectrum antibiotic use after allogeneic hematopoietic stem cell transplantation in human patients and mice. Sci Transl Med 8:339ra71
Hobbs, G S; Kaur, N; Hilden, P et al. (2016) A novel reduced intensity conditioning regimen for patients with high-risk hematological malignancies undergoing allogeneic stem cell transplantation. Bone Marrow Transplant 51:1010-2
Huang, Yao-Ting; Neofytos, Dionysios; Foldi, Julia et al. (2016) Cytomegalovirus Infection after CD34(+)-Selected Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant 22:1480-6

Showing the most recent 10 out of 392 publications