Biostatistics Core

生物统计学核心

• 批准号: 7408319
• 负责人: JAMES J SCHLESSELMAN
• 金额: $ 9.17万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-10-01 至 2012-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7408319
• 关键词: Awareness; Basic Science; Biometry; Biostatistics Core; Clinical; Clinical Research; Clinical Trials; Data; Development; Ensure; Epidemiologic Studies; Funding; Immune response; In Vitro; Informatics; Investigation; Laboratories; Light; Malignant Neoplasms; Manuscripts; Phase; Phase I Clinical Trials; Progress Reports; Protocols documentation; Reporting; Reproduction spores; Research; Research Personnel; Research Project Grants; Role; Safety; Scientist; Services; Treatment Efficacy; University of Pittsburgh Cancer Institute; Work; Writing; abstracting; base; behavioral health; cancer prevention; cancer therapy; career; design; in vivo; oncology; programs; research study; sound

CORE C (Biostatistics) will reside within the University of Pittsburgh Cancer Institute's (UPCI) Biostatistics Facility, which provides clinical and basic-science investigators in UPCI with statistical expertise in design, analysis, and reporting of cancer-related research studies. These cover basic-science studies; phase I and phase II oncology clinical trials; epidemiologic studies, including those related to cancer prevention and awareness; and investigations of behavioral and health sequelae of cancer treatment. In its role as Core C for this Program Project, the Biostatistics Core will support all five research projects. We will collaborate with investigators on statistical aspects of the design of in vitro and in vivo laboratory-based studies as new data come to light, and perform both exploratory and confirmatory statistical analyses of the resulting data from key experiments in Projects 1 - 5. For the clinical trial that is planned (Project 4), we will collaborate with basic scientists and clinicians on further developing and finalizing a protocol that is methodologically sound, and that will pass scientific, ethical, and regulatory review. We will perform interim analyses of safety for the SPORE's clinical trials (Projects 2, 3 & 4), and final analyses of their data on safety, immune response, and treatment efficacy. We will contribute to the review of the SPORE's developmental research-program proposals, and provide statistical support to those that are funded. We will provide statistical support to the career-development awardees. We will work with the project investigators, with Core D (Informatics), and with UPCI Clinical Research Services, a component of Core A, to ensure that the requisite laboratory and clinical-trial data are available for statistical analyses. We will collaborate with the project investigators in writing and preparing progress reports, abstracts, manuscripts, and presentations.

Core C（生物统计学）将居住在匹兹堡大学癌症研究所（UPCI）生物统计学中 设施，该设施为UPCI的临床和基本科学研究人员提供了设计方面的统计专业知识， 分析和与癌症相关研究的报告。这些涵盖了基本科学研究；第一阶段和 第二阶段肿瘤学临床试验；流行病学研究，包括与预防癌症有关的研究和 意识;以及对癌症治疗的行为和健康后遗症的研究。作为核心C的角色 对于该计划项目，生物统计学核心将支持所有五个研究项目。我们将与 研究人员在体外和体内实验室研究设计的统计方面作为新数据 揭露，并对来自 项目1-5的主要实验。对于计划的临床试验（项目4），我们将与 基础科学家和临床医生，正在进一步制定和敲定方法论上是合理的方案， 这将通过科学，道德和监管审查。我们将对安全性进行临时分析 孢子的临床试验（项目2、3和4），以及有关安全性，免疫反应和 治疗功效。我们将为综述孢子的发展研究贡献做出贡献 提案，并向资助的人提供统计支持。我们将向 职业发展获奖者。我们将与项目调查员，核心D（信息学）和 借助核心A组成部分的UPCI临床研究服务，以确保必要的实验室和 临床试验数据可用于统计分析。我们将与项目调查人员合作 写作和准备进度报告，摘要，手稿和演示文稿。