Administrative, Statistical, and Regulatory

行政、统计和监管

• 批准号: 8518924
• 负责人: Pawel Kalinski
• 金额: $ 1.93万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-05 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8518924
• 关键词: Awareness; Basic Science; Biometry; Biostatistics Core; Clinical; Clinical Research; Clinical Trials; Communication; Data; Ensure; Epidemiologic Studies; Ethics; Grant; Immune response; In Vitro; Informatics; Investigation; Laboratories; Malignant Neoplasms; Manuscripts; Occupational activity of managing finances; Phase; Progress Reports; Reporting; Research; Research Personnel; Research Project Grants; Safety; Scientist; Services; T-Lymphocyte; Treatment Efficacy; United States National Institutes of Health; University of Pittsburgh Cancer Institute; Work; Writing; abstracting; base; behavioral health; cancer prevention; cancer therapy; data sharing; design; in vivo; meetings; oncology; programs; protocol development; research study; sound; tumor

The Biostatistics component of the Administrative-Biostatistics Core 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. Biostatistics will support all three 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. For the clinical trials that are planned in Project 1 and Project 3, we will collaborate with basic scientists and clinicians on finalizing the development of protocols that are methodologically sound, and that will pass scientific, ethical, and regulatory review. We will perform interim analyses of safety for the clinical trials, and final analyses of their data on safety, immune response, and treatment efficacy. We will work with the project investigators, UPCI Informatics, and with UPCI Clinical Research Services 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.

行政生物统计学核心的生物统计学部分将驻留在大学内。 匹兹堡癌症研究所（UPCI）的生物统计设施，提供临床和基础科学 UPCI的研究者在癌症相关研究的设计、分析和报告方面具有统计学专业知识 问题研究这些包括基础科学研究; I期和II期肿瘤学临床试验;流行病学研究; 研究，包括与癌症预防和认识有关的研究; 癌症治疗的健康后遗症。生物统计学将支持所有三个研究项目。我们将合作 与研究人员就体外和体内实验室研究设计的统计学方面进行了讨论， 数据曝光，并对所得数据进行探索性和验证性统计分析 关键实验。对于项目1和项目3中计划的临床试验，我们将合作 与基础科学家和临床医生一起， 健全的，这将通过科学，道德和监管审查。我们将对安全性进行中期分析， 用于临床试验，并对其安全性、免疫应答和治疗效果数据进行最终分析。我们 将与项目研究者、UPCI信息学和UPCI临床研究服务部合作， 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，撰写和准备进度报告、摘要、手稿， 和介绍。