Core--Administration, Biostatistics, Data Management

该计划将接口临床和组织培养研究，将利用树突状细胞在 诱导对黑色素瘤的强免疫力。一个行政核心将履行与下列方面相联系的职能： 3个子项目，并以细胞生产和免疫监测为核心。行政 核心将包括在达拉斯和纽约的行政助理，他们将履行以下职能：（1）运送患者 在核心和交互式实验目标中待测定的样品和血清;（2） 在纽约和达拉斯安排调查人员和外部顾问之间的联席会议;（3）准备 向机构审查委员会提交方案并进行年度更新;（4）安排联系， 准备向NCI提交的报告;（5）获取并维护治疗、血液和组织的知情同意书 抽样;（6）帮助准备，提交和跟踪手稿;（7）输入和维护共享的参考数据 基地;（8）监控预算;（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。贝勒与 研究所和生物统计公司，统计合作，以解决所有生物统计问题 需要在BUR。公司总裁珍妮特·威茨博士是一位受人尊敬的生物统计学家， 作为项目的合作者。这个小组在试验的设计中有着重要的投入 在这份修订的申请中。一个五人的外部咨询委员会已同意为 计划，包括在树突状细胞，人类免疫治疗领域的杰出研究人员， 黑色素瘤，调节性T细胞的生物学和人骨髓瘤的免疫疗法。

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.