Core--Data management

核心--数据管理

• 批准号: 6661535
• 负责人: KATHRYN HIRST
• 金额: $ 20.93万
• 依托单位: STEWARD ST. ELIZABETH'S MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6661535
• 关键词: biomedical facility; clinical trials; data management; statistical service /center; statistics /biometry

This Program Project Grant application (PPG) seek funding for a Program of Excellence in Gene Therapy (PEGT) at St. Elizabeth's Medical Center (SEMC)/Tufts University School of Medicine Center, George Washington University, Rockville, MD. The PPG consists of three Clinical Projects and two Pre-clinical Projects, supported by four Cores. Dr. Jeffrey M. Isner, Principal Investigator (P.I.) with overall responsibility for the PPG, will serve as Project Director for (clinical) Project 1, "VEGF Gene Transfer for Diabetic Neuropathy." Dr. Douglas Losordo will direct (clinical) Project 2, "VEGF Gene Transfer to Prevent Coronary Artery Restonosis." (Clinical) Project 3, "VEGF Gene Transfer to Promote Angiogenesis in Patients with Advanced Heart Failure, will be directed by Dr. Patrick McCarthy, Surgical Director of the Cleveland Clinic Kaufman Center for Heart Failure." Dr. Takayuki Asahara will direct (pre-clinical) Project 5, "Endothelial Progenitor Cell Gene Transfer." The research productivity and functional capacity of the PPG will enhanced by four Cores, the Plasmid Core, will provide clinical grade plasmid DNA vector, and will be supervised by administrative assistance. Drs, Losordo and Walsh will also direct the Training Core. Core, the Data Management Core, directed by Kathryn Hirst, PhD. Research Associate Professor of the Biostatistics Center, George Washington University will assist with data management and analysis, and will also ensure compliance with all appropriate regulatory bodies. The studies and organization outlined in this PPG are intended to provide high quality and credible clinical as well as pre-clinical research studies of gene transfer that will represent meaningful contributions to both the scientific community and lay public.

本计划项目资助申请（PPG）旨在为位于马里兰州罗克维尔的华盛顿大学乔治医学院中心的圣伊丽莎白医学中心（SEMC）/塔夫茨大学医学院的基因治疗卓越计划（PEGT）寻求资助。PPG包括三个临床项目和两个临床前项目，由四个核心支持。Jeffrey M.博士Isner，主要研究者（P.I.）全面负责PPG，将担任（临床）项目1“糖尿病神经病变的VEGF基因转移”的项目总监。“道格拉斯洛索多博士将指导（临床）项目2，“血管内皮生长因子基因转移，以防止冠状动脉再狭窄。“（临床）项目3，“血管内皮生长因子基因转移，以促进晚期心力衰竭患者的血管生成，将由帕特里克麦卡锡博士，外科主任克利夫兰诊所考夫曼心力衰竭中心。浅原隆之博士将指导（临床前）项目5，内皮祖细胞基因转移。“PPG的研究生产力和功能能力将通过四个核心得到加强，即质粒核心，将提供临床级质粒DNA载体，并将由行政协助监督。博士，洛索多和沃尔什也将指导培训核心。核心，数据管理核心，由Kathryn Hirst博士指导。乔治华盛顿大学生物统计中心的研究副教授将协助数据管理和分析，并将确保遵守所有适当的监管机构。本PPG中概述的研究和组织旨在提供高质量和可信的基因转移临床和临床前研究，这些研究将为科学界和公众做出有意义的贡献。