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.

摘要核心A：行政和生物统计 行政核心(核心A)将提供临床和科学领导、有效沟通和 财务和生物统计方面的支持，以确保所有计划项目活动的成功。这项建议 寻求通过增强嵌合抗原来巩固我们在基因工程T细胞治疗方面的记录 受体T细胞平台，专门解决我们在临床上观察到的系统性弱点 到目前为止的试验。我们的主要假设是，新的基因编辑方法可以去除剩余的 普遍可用和普遍活跃的CAR T细胞治疗血液病道路上的障碍 恶毒。我们召集了一批杰出的调查人员，他们合作并 多年来共同出版。每个以疾病为重点的项目都将由一个公认的权威机构领导 菲尔德。支持这一提议的三个核心对我们的临床CAR T细胞的成功至关重要 到目前为止的计划和他们的专业知识将为这项提议的成功奠定基础。每个项目的核心部分 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、行政人员和中心的中央研究组织 佩雷尔曼医学院的细胞免疫疗法，以实现我们的目标。强大的机构 阿布拉姆森癌症中心、佩雷尔曼医学院和华盛顿大学的承诺 宾夕法尼亚州为我们的科学和翻译成就提供了便利。基本服务 核心A提供的服务包括：为每个项目和核心中的所有调查员提供行政支助；财政 管理和监督计划项目的所有组成部分；以及组织和沟通 所有计划项目会议和活动。这一核心的总体目标是有效和高效地领导 P01。主任、协查人员和行政人员的作用是促进沟通和 组织结构，同时促进科技互动。为了实现这一目标， 中心确立了四个目标：(1)监督宾夕法尼亚大学的安全和监测活动 (2)为临床试验、项目和核心提供统计支持，并实施 计划促进数据共享；(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NCI人员关于有效执行 拟议目标；(4)提供预算服务，如跟踪费用和提供调查员 月报。