Core--Administration, Biostatistics, Data Management

该计划将结合临床和组织培养研究，利用树突状细胞在 对黑色素瘤有很强的免疫力。管理核心将执行与 3个子项目，以细胞生产和免疫监测为核心。行政部门 核心将包括达拉斯和纽约的行政助理，他们的职能是：(1)运送病人 将在岩心和互动实验目标中进行分析的样本和血清； 在纽约和达拉斯安排调查人员和外部顾问的联席会议；(3)准备 向机构审查委员会提交议定书和每年更新；(4)安排接触和 准备向NCI提交的报告；(5)获取和维护治疗、血液和组织的知情同意 抽样；(6)帮助准备、提交和跟踪稿件；(7)输入和维护共享的参考数据 基地；(8)监督预算；(9)管理人员，包括移民、津贴、福利和住房；(10) 协调设备的维护和维修。行政核心将支持集中的生物统计 以及纽约和达拉斯的数据管理人员。贝勒已经签署了一份合同 研究机构和生物统计公司，统计合作，以解决所有生物统计问题 在BUR需要。该公司总裁珍妮特·威特斯博士是一位受人尊敬的生物统计学家，他将 作为计划项目的合作者。这个小组在试验的设计中有很大的投入 在这份修订的申请中提出。一个由五人组成的外部咨询委员会已同意为 项目，包括树突状细胞、人类免疫疗法等领域的杰出研究人员 黑色素瘤、调节性T细胞生物学和人类骨髓瘤的免疫治疗。

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.