Core A: Administrative and Biostatistics Core

核心 A：行政和生物统计学核心

• 批准号: 10245066
• 负责人: CARL H. JUNE
• 金额: $ 15.12万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10245066
• 关键词: Achievement; Address; Annual Reports; Basic Science; Biometry; Biostatistics Core; Budgets; CAR T cell therapy; Cancer Center; Cellular immunotherapy; Clinical; Clinical Trials; Communication; Data; Disease; Doctor of Philosophy; Ensure; Genes; Genetic Engineering; Goals; Hematologic Neoplasms; Human Resources; Infrastructure; Leadership; Learning; Monitor; Operations Research; Pennsylvania; Physician Executives; Progress Reports; Publishing; Reporting; Research; Research Personnel; Role; Safety; Schedule; Scientist; Services; Structure; T cell therapy; Testing; TimeLine; Universities; Update; authority; chimeric antigen receptor T cells; clinical research site; clinical trial implementation; data sharing; design; innovation; medical schools; meetings; novel; operation; organizational structure; pharmacovigilance; preservation; programs; response; success

SUMMARY CORE A: ADMINISTRATIVE AND BIOSTATISTICS The Administrative Core (Core A) will provide clinical and scientific leadership, effective communication and fiscal and bio-statistical support to ensure the success of all Program Project activities. This proposal seeks to build upon our track record in genetically engineered T cell therapy by enhancing the chimeric antigen receptor T cell platform to specifically address systemic vulnerabilities that we have observed in our clinical trials to date. Our overarching hypothesis is that novel gene editing approaches can remove the remaining obstacles in the path of universally-available and universally-active CAR T cell therapy for hematologic malignancy. We have brought together a cadre of exceptional investigators who have collaborated and published together for many years. Each disease-focused project will be led by a recognized authority in the field. The three cores that support this proposal have been critical to the success of our clinical CAR T cell program to date and their expertise will underpin the success of this proposal. The centerpiece of each project is an innovative clinical trial that seeks to test our major hypotheses. We are leveraging the proven translational infrastructure, administrative staff and the centralized research organizations at the Center for Cellular Immunotherapies at the Perelman School of Medicine to achieve our objectives. Strong institutional commitment from the Abramson Cancer Center, Perelman School of Medicine and the University of Pennsylvania have facilitated our scientific and translational achievements. The essential services provided by Core A include: administrative support for all of the investigators in each project and core; fiscal management and oversight for all components of the Program Project; and organization and communication of all Program Project meetings and activities. The overall goal of this Core is effective and efficient leadership of the P01. The roles of the Director, Co-investigators and administrative staff are to facilitate communication and organizational structure while stimulating scientific and technological interactions. In order to achieve this goal, the Core has established four objectives: (1) To oversee the safety and monitoring activities for Penn and CHOP clinical sites; (2) To provide statistical support for clinical trials, projects and cores and implement plans to promote data sharing; (3) To coordinate the interactions among clinicians and scientists in projects and cores, internal and external advisory boards, and NCI personnel regarding effective implementation of proposed objective; (4) To provide budgetary services such as tracking expenses and providing investigator's monthly reports.

核心A摘要：行政和生物统计 行政核心（核心A）将提供临床和科学领导，有效的沟通， 财政和生物统计支持，以确保所有计划项目活动的成功。这项建议 旨在通过增强嵌合抗原， 受体T细胞平台，专门解决我们在临床研究中观察到的系统性脆弱性， 审判至今。我们的总体假设是，新的基因编辑方法可以去除剩余的 普遍可用和普遍活性的CAR T细胞治疗血液病的障碍 恶性肿瘤我们召集了一批杰出的调查人员，他们相互合作， 一起出版多年。每一个以疾病为重点的项目都将由一个公认的权威机构领导， 领域支持这一提议的三个核心对于我们临床CAR T细胞的成功至关重要。 他们的专业知识将支持这项建议的成功。每个项目的核心 是一项创新的临床试验，旨在测试我们的主要假设。我们正在利用经过验证的 翻译基础设施，行政人员和中心的集中研究组织， 细胞免疫疗法在佩雷尔曼医学院，以实现我们的目标。坚强体制 来自艾布拉姆森癌症中心，佩雷尔曼医学院和大学的承诺 宾夕法尼亚州促进了我们的科学和翻译成就。基要服务 核心A提供的支助包括：为每个项目和核心的所有调查人员提供行政支助; 管理和监督计划项目的所有组成部分;组织和沟通 所有项目会议和活动。该核心的总体目标是有效和高效地领导 P01。主任、共同调查员和行政工作人员的作用是促进沟通， 组织结构，同时促进科学技术的互动。为了实现这一目标， 核心计划确定了四个目标：（1）监督宾夕法尼亚大学的安全和监测活动 和CHOP临床研究中心;（2）为临床试验、项目和核心提供统计支持， 促进数据共享的计划;（3）协调项目中临床医生和科学家之间的互动 和核心，内部和外部咨询委员会，以及国家癌症研究所人员关于有效实施 （4）提供预算服务，如跟踪费用和提供调查员的 月度报告。