BIOSTATISTICS AND CLINICAL CORE

生物统计和临床核心将提供支持实验室所需的领导和专业知识 并对这4个项目进行了临床研究。 临床部分将由Prados博士领导，他将与项目负责人互动，开发临床 特别是在项目三和项目四的实验室调查基础上进行的试验，以及讨论 项目一和项目二的结果可能导致相关的生物标志物和潜在的分层因素 未来或潜在的临床试验。临床部分将支持孢子临床的实际开展。 试验，包括提供临床医生、研究护士和数据协调员，并协助所有必要的 这些研究的监管报告。普拉多斯博士将支持和促进项目的互动 与CTEP、合作团体、生物制药和行业团体合作获得新的治疗方法 适合于设计来自项目三和项目四的新研究的代理，以及 根据需要支持对这些群体进行孢子临床试验。 生物统计学部分将由Molinaro博士领导，他将与 来自所有四个项目的个人领导人评估每个项目的统计需求。生物统计学部分 将提供：关于实验和临床研究设计的建议，包括计算样本量和 能力；数据分析支持(通过在核心内执行分析或向符合条件的人员提供建议 项目内人员)，包括使用适当的统计模型和应用 统计检验；以及在必要时开发新方法以帮助解释以下结果 实验。此外，生物统计部门的一名成员将参加定期安排的 项目会议，以提供统计/生物信息学投入，并协助准备必要的材料 演示文稿和出版。

The Biostatistics and Clinical Core will provide the leadership and expertise needed to support the laboratory and clinical researeh ofthe 4 Projects of this SPORE grant. The Clinical component will be led by Dr. Prados, who will interact with Project leaders to develop clinical trials based upon laboratory investigations in Projects Three and Four in particular, as well as to discuss results in Projects One and Two that may lead to relevant biomarkers and potential stratification factors for future or potential clinical trials. The Clinical component will support the actual conduct of SPORE clinical trials, including providing clinicians, research nurses and data coordinators, and assist in all of the required regulatory reporting for those studies. Dr. Prados will support and facilitate the interactions of Project leaders with CTEP, cooperative groups, biopharmaceutical, and industry groups to obtain new therapeutic agents appropriate to the design of new studies that come from Projects Three and Four, as well as supporting the conduct of SPORE clinical trials to those groups as needed. The Biostatistical component wilt be led by Dr. Molinaro, who will interact on an ongoing basis with the individual leaders from all four Projects to assess the statistical needs of each. The Biostatistical component will provide: advice on the design of experimental and clinical studies, including calculating sample sizes and power; data analysis support (either by performing the analyses within the core or advising qualified personnel within the projects), including the use of appropriate statistical models and applications of statistical test; and, when necessary, the development of novel methods to help interpret results from experiments. Additionally, a member of the Biostatistical component will participate in regularly scheduled project meetings to provide statistical/bioinformatics input and assist in preparing the necessary materials for presentation and publication.