Administrative/Clinical/Biostatistics Core

行政/临床/生物统计学核心

• 批准号: 8475914
• 负责人: Steven P. Balk
• 金额: $ 14.15万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-05-24 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8475914
• 关键词: Androgen Receptor; Biometry; Biostatistics Core; Clinic; Clinical; Clinical Distribution; Clinical Trials; Code; Collaborations; Communication; Computational Biology; Conduct Clinical Trials; Dana-Farber Cancer Institute; Development; Disease; Experimental Designs; Foundations; Goals; Individual; Institution; Instruction; Malignant neoplasm of prostate; Patients; Phase; Research Personnel; Resources; Sampling; Serum; Staging; Tissue Banking; Tissue Banks; Tissues; Translating; castration resistant prostate cancer; clinically significant; design; meetings; pre-clinical; preclinical study

PROJECT SUMMARY (See instructions): Core A will fulfill three major functions. One function is the overall management of the POI, which will be the responsibility of the Pl (Steven Balk) and the co-investigator (Peter Nelson). They will insure that administrative and regulatory requirements are met, but their main focuses will be on enhancing communication and collaboration between the Projects and on optimizing the use of the resources provided by the P01. The second function of the Core is to assist the Projects in efforts to translate their findings into patients. In addition to Drs. Balk and Nelson, Core A includes three investigators with a major focus on the design and conduct of clinical trials in prostate cancer (Drs. Mary-Ellen Taplin, Bruce Montgomery, and Glenn Bubley). Through previous/ongoing clinical trials and tissue banking efforts at their respective institutions, these investigators have collected valuable tissue and serum samples from patients at varying stages of their disease and after varying therapies. In discussions with the Project Leaders, they will facilitate the identification and distribution of relevant coded clinical samples for analysis by the Projects, and will assist in interpreting the clinical significance of the results. Moreover, Drs. Taplin, Montgomery and Bubley will assist the Project Leaders in the design and conduct of preclinical studies that can form the foundation for subsequent phase I or phase 11 clinical trials. The third Core function is to provide statistical support for each of the Project Leaders in their experimental designs. Lillian Werner, in the Department of Biostatistics and Computational Biology at DFCI, who also directs the DF/HCC Prostate Cancer SPORE Biostatistics and Computational Biology Core, is dedicating 10% effort specifically to this P01. The specific aims are: Aim 1. Provide administrative support to insure that the goals of the project are achieved. Aim 2. Assist in translating the results from each Project into the clinic. Aim 3. Provide biostatistical support for each Project.

项目总结（见说明）： 核心A将实现三大功能。一项职能是POI的总体管理，这将由PI（Steven Balk）和合作研究者（Peter纳尔逊）负责。他们将确保满足行政和监管要求，但他们的主要重点将是加强项目之间的沟通和合作，以及优化P01提供的资源的使用。核心小组的第二个职能是协助项目努力将其研究结果转化为患者。除了Balk和纳尔逊博士外，核心A还包括三名主要关注前列腺癌临床试验设计和实施的研究者（Mary-Ellen Taplin、布鲁斯蒙哥马利和Glenn Bubley博士）。通过之前/正在进行的临床试验和各自机构的组织库工作，这些研究人员从处于不同疾病阶段和不同治疗后的患者中收集了有价值的组织和血清样本。在与项目负责人的讨论中，他们将促进相关编码临床样本的识别和分发，以供项目分析，并将协助解释结果的临床意义。此外，Taplin、蒙哥马利和Bubley博士将协助项目负责人设计和开展临床前研究，为后续I期或11期临床试验奠定基础。第三个核心功能是为每个项目负责人的实验设计提供统计支持。DFCI生物统计学和计算生物学系的Lillian Werner也是DF/HCC前列腺癌SPORE生物统计学和计算生物学核心的负责人，她专门为此P01投入了10%的精力。具体目标是： 目标1.提供行政支持，以确保项目目标的实现。 目标2.协助将每个项目的成果转化到临床。 目标3.为每个项目提供生物统计支持。