Core--Administration, Biostatistics, Data Management

核心——行政管理、生物统计、数据管理

• 批准号: 7631321
• 负责人: Jacques F Banchereau
• 金额: $ 3.69万
• 依托单位: BAYLOR RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7631321
• 关键词: Address; Advisory Committees; Amendment; Antibodies; Autoimmunity; B-Lymphocytes; Biological Assay; Biology; Biometry; Blood; Budgets; Cells; Cellular biology; Clinical; Contracts; Data; Databases; Dendritic Cells; Development; District of Columbia; Doctor of Philosophy; Equipment; Expenditure; France; Government; Head; Housing; Human; Human Resources; Immigration; Immunity; Immunologic Monitoring; Immunology; Immunotherapy; Informed Consent; Institutes; Insurance; Intellectual Property; Interleukins; Joints; Laboratories; Laboratory Animals; Mails; Maintenance; Manuscripts; Monitor; Multiple Myeloma; Multivariate Analysis; Myelopoiesis; New York; Patients; Peer Review; Peptides; Persons; Positioning Attribute; Preparation; Principal Investigator; Production; Protocols documentation; Publications; Recruitment Activity; Reporting; Research; Research Ethics Committees; Research Institute; Research Personnel; Resource Sharing; Retrieval; Running; Sampling; Score; Serum; Shipping; Ships; System; T-Lymphocyte; Telephone; Time; Tissue Sample; Travel; United States Food and Drug Administration; Universities; Work; cytokine; data management; design; experience; melanoma; programs; repaired; skills; statistics; tissue culture; tumor immunology

This program will interface clinical and tissue culture studies that will exploit dendritic cells in the induction of strong immunity to melanoma. An administrative core will carry out functions that interface with the 3 subprojects and with the cores for cell production and for immunologic monitoring. The administrative core will include administrative assistants in Dallas and New York who will function to: (1) Ship patient samples and sera that are to be assayed in the cores and in the interactive experimental aims; (2) To arrange joint meetings between the investigators and external advisors in New York and Dallas; (3) Prepare protocol submissions and annual renewals to the institutional review boards; (4) Arrange contacts and prepare reports to the NCI; (5) Procure and maintain informed consents for therapies, blood, and tissue sampling; (6) Help to prepare, submit, and track manuscripts; (7) Enter and maintain a shared reference data base; (8) Monitor budgets; (9) Manage personnel including immigration, stipends, benefits and housing; (10) Coordinate equipment maintenance and repair. The administrative core will support centralized biostatistics and data management personnel in New York, and Dallas. A Contract has been signed between Baylor Research Institute and biostatistical firm, Statistics Collaborative, to address all the biostatistics matter needed at BUR. The president of the company, Janet Wittes, PhD, is a respected Biostatistician who will serve as a collaborator to the Program Project. This group has had a major input in the design of the trials proposed in this revised application. A five person external advisory committee has agreed to serve the program and includes outstanding investigators in the fields of dendritic cells, immunotherapy of human melanoma, biology of Regulatory T cells, and immunotherapy of human myeloma.

该计划将结合临床和组织培养研究，利用树突状细胞 诱导对黑色素瘤的强大免疫力。管理核心将执行与接口交互的功能 3个子项目的核心是细胞生产和免疫监测。行政方面 核心人员将包括达拉斯和纽约的行政助理，其职责是：(1) 运送患者 将在核心和交互式实验目标中进行分析的样品和血清； (2) 至 安排调查人员与外部顾问在纽约和达拉斯举行联席会议； (3)准备 向机构审查委员会提交方案并进行年度更新； (4) 安排联络及 准备向 NCI 提交的报告； (5) 获得并维持治疗、血液和组织的知情同意 采样; (6) 帮助准备、提交、跟踪稿件； (7) 输入和维护共享参考数据 根据; （八）监督预算； （九）人员管理，包括移民、津贴、福利和住房； (10) 协调设备维护和维修。行政核心将支持集中式生物统计 以及纽约和达拉斯的数据管理人员。贝勒与贝勒签署了一份合同 研究所和生物统计公司，Statistics Collaborative，解决所有生物统计问题 BUR 需要。该公司总裁 Janet Wittes 博士是一位受人尊敬的生物统计学家，她将 作为该计划项目的合作者。该小组对试验设计做出了重要贡献 在此修订后的申请中提出。五人外部咨询委员会已同意为 计划，包括树突状细胞、人类免疫治疗领域的杰出研究人员 黑色素瘤、调节性 T 细胞生物学以及人类骨髓瘤的免疫治疗。