The primary role of the biostatistics and data management core is to provide collaboration on quantitative aspects of the design, conduct and analysis of clinical protocols, including protocol review and sample size projections at the design stage, forms development, data extraction computerized database management and quality control, and analysis of data for abstracts, manuscripts, and presentations. In the past, much of this collaboration has been undertaken within specialized research areas. The coordination of diverse but related activities through the program project orientation allows for centralization of many of the biostatistical and data management activities which would otherwise be undertaken individually and without the advantages offered through joint collaboration. The primary purpose of this core is to provide high level biostatistical and data management expertise under the centralized direction of the principal investigator of the program project.
Specific aims of the core include: 1. To provide biostatistical expertise for clinical protocol design and for planning and interpreting sequences of related protocols. 2. To provide forms design, data management support, and quality control for clinical protocols and laboratory projects reflecting the maturation of the clinical and laboratory hypotheses. 3. To provide clinical data management for collection of individual patient information. 4. To provide interim reports for ongoing studies and more detailed statistical analyses of final study results. To collaborate on dissemination of these results via abstracts, manuscripts and presentations. 5. To conduct statistical analyses using the BMT database to compare outcomes and identify prognostic factors across protocols, when appropriate.
|Exley, Mark A; Friedlander, Phillip; Alatrakchi, Nadia et al. (2017) Adoptive Transfer of Invariant NKT Cells as Immunotherapy for Advanced Melanoma: A Phase I Clinical Trial. Clin Cancer Res 23:3510-3519|
|Matsuoka, Ken-ichi; Koreth, John; Kim, Haesook T et al. (2013) Low-dose interleukin-2 therapy restores regulatory T cell homeostasis in patients with chronic graft-versus-host disease. Sci Transl Med 5:179ra43|
|Brown, J R; Kim, H T; Armand, P et al. (2013) Long-term follow-up of reduced-intensity allogeneic stem cell transplantation for chronic lymphocytic leukemia: prognostic model to predict outcome. Leukemia 27:362-9|
|Jacobson, Caron A; Turki, Amin T; McDonough, Sean M et al. (2012) Immune reconstitution after double umbilical cord blood stem cell transplantation: comparison with unrelated peripheral blood stem cell transplantation. Biol Blood Marrow Transplant 18:565-74|
|Kawano, Yutaka; Kim, Haesook T; Matsuoka, Ken-Ichi et al. (2011) Low telomerase activity in CD4+ regulatory T cells in patients with severe chronic GVHD after hematopoietic stem cell transplantation. Blood 118:5021-30|
|Koreth, John; Matsuoka, Ken-ichi; Kim, Haesook T et al. (2011) Interleukin-2 and regulatory T cells in graft-versus-host disease. N Engl J Med 365:2055-66|
|Schoenfeld, Jonathan D; Dranoff, Glenn (2011) Anti-angiogenesis immunotherapy. Hum Vaccin 7:976-81|
|Brown, Julia A; Stevenson, Kristen; Kim, Haesook T et al. (2010) Clearance of CMV viremia and survival after double umbilical cord blood transplantation in adults depends on reconstitution of thymopoiesis. Blood 115:4111-9|
|Matsuoka, Ken-ichi; Kim, Haesook T; McDonough, Sean et al. (2010) Altered regulatory T cell homeostasis in patients with CD4+ lymphopenia following allogeneic hematopoietic stem cell transplantation. J Clin Invest 120:1479-93|
|Sarantopoulos, Stefanie; Stevenson, Kristen E; Kim, Haesook T et al. (2009) Altered B-cell homeostasis and excess BAFF in human chronic graft-versus-host disease. Blood 113:3865-74|
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