Data Management & Statistical Core

数据管理

• 批准号: 10598377
• 负责人: MICHAEL JOSEPH SCHELL
• 金额: $ 2.69万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-03 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10598377
• 关键词: Address; Affect; Africa South of the Sahara; Anus; Award; Bioinformatics; Biometry; Biostatistical Methods; Cancer Center; Cervical; Clinical; Clinical Management; Clinical Protocols; Clinical Research; Collaborations; Communities; Consult; Data; Databases; Development; Education; Ensure; Etiology; Experimental Designs; Future; Genetic Transcription; Goals; Guidelines; HIV; HPV analysis; Housing; Human Herpesvirus 4; Human Papillomavirus; Immune; Immunofluorescence Immunologic; Informatics; Infrastructure; International; Investigation; Investments; Knowledge; Laboratories; Lead; Malignant neoplasm of penis; Malignant neoplasm of vulva; Manuscripts; Mentorship; Methodology; Monitor; Oncology; Peer Review; Persons; Phase; Pilot Projects; Policies; Population; Procedures; Publications; Qualifying; Questionnaires; Reproducibility; Research; Research Personnel; Research Project Grants; Resources; Sample Size; Serology; Site; South Africa; Statistical Data Interpretation; Training and Education; Translational Research; Tumor-infiltrating immune cells; Universities; Viral; Work; Writing; Zimbabwe; biological specimen archives; cancer epidemiology; career; data management; data repository; design; epidemiology study; flexibility; investigator training; lectures; low and middle-income countries; malignant oropharynx neoplasm; member; power analysis; protocol development; rare cancer; research study; statistics; tumor; viral DNA; virtual

PROJECT SUMMARY – DATA MANAGEMENT & STATISTICS CORE The overarching goal of the Data Management & Statistics Core (DMSC) for the Partnership to Assess Viral and Immune Landscape Intersections with Oncology for People Living with HIV (PAVILION) is to provide comprehensive statistical design, data management, and analysis in support of conducting rigorous and reproducible research by PAVILION investigators who are working to make strides in understanding the proportion of tumors whose etiology is attributable to the human papillomavirus (HPV) and Epstein-Barr virus (EBV) among people living with HIV in sub-Saharan Africa including such rare tumor types as anal, cervical, conjunctival, oropharyngeal, penile, and vulvar cancers. The DMSC will be led by Dr. Michael Schell, who is exceptionally qualified in the design, analysis, and management of clinical and epidemiological studies. The DMSC has designed a robust yet flexible pipeline that builds upon the extensive infrastructure and long-term international collaborations established by the PAVILION partnering investigators including those of the HIM1, BROADEN2, and EVRI3 international study teams. It leverages the extensive investment by Moffitt Cancer Center in biostatistics, bioinformatic, informatic, and computing capabilities as well as the depth and breadth of expertise in the analysis of basic, translational, clinical, and large-scale cancer epidemiological studies to address project aims and build biostatistical capacity at Stellenbosch University (South Africa) and University of Zimbabwe, the PAVILION low- and middle-income country (LMIC) sites. Further, the DMSC will provide education and training through lectures and mentorship in biostatistics to members and research staff, with the goal of building the expertise and capacity of the LIMC partner sites to lead future studies/trials. To achieve the overarching goal, the DMSC will provide statistical and analytical design, sample size determination, continuous monitoring of accumulating data, statistical analysis of results, and manuscript development for peer reviewed publication. These activities are organized into the following Specific Aims: Aim 1: Provide statistical support for the design, conduct, and data management of planned and future PAVILION studies This aim provides support for the initial experimental design and data accumulation phases of the proposed and future PAVILION projects. Aim 2: Lead statistical analysis of data produced by PAVILION studies for peer reviewed publication This aim provides hands on statistical support for analyzing downstream data produced by the proposed translational research projects and any pilot projects awarded through the Developmental Core. Aim 3: Educate and train investigators at PAVILION LMIC partnering sites on biostatistical methods and resources needed for large scale epidemiological studies This aim provides hands on mentorship of two early career biostatisticians in South Africa and Zimbabwe to expand regional capacity in the rigorous design and reproducible conduct of broad scale clinical and epidemiological studies in sub-Saharan Africa.

项目摘要 - 数据管理和统计核心 数据管理与统计核心（DMSC）的总体目标是评估病毒和 免疫景观与肿瘤学的交集，用于艾滋病毒（Pavilion）的人（Pavilion）提供 全面的统计设计，数据管理和分析，以支持进行严格和 凉亭调查员的可重复研究，他们正在努力理解 病因归因于人乳头瘤病毒（HPV）和爱泼斯坦 - 巴尔病毒的肿瘤比例 （EBV）在撒哈拉以南非洲的艾滋病毒感染者中，包括肛门，宫颈，宫颈， 结膜，口咽，阴茎和外阴癌。 DMSC将由Michael Schell博士领导 在临床和流行病学研究的设计，分析和管理中具有异常资格。 DMSC设计了一条强大而灵活的管道，建立在广泛的基础设施和长期基础上 亭子合作调查员建立的国际合作，包括HIM1的调查员 BRODEN2和EVRI3国际研究团队。它利用莫菲特癌症中心的大量投资 在生物统计学中，生物信息学，信息丰富和计算功能以及专业知识的深度和广度 在分析基本，翻译，临床和大规模癌症流行病学研究中，以解决项目 在斯特伦博斯大学（南非）和津巴布韦大学的目标和建立生物统计能力 凉亭低收入和中等收入国家（LMIC）地点。此外，DMSC将提供教育和培训 通过向成员和研究人员进行生物统计学的讲座和心态，目的是建立 LIMC合作伙伴站点的专业知识和能力领导未来的研究/试验。为了实现总体目标， DMSC将提供统计和分析设计，样本量确定，连续监视 累积数据，结果统计分析以及同行评审出版物的手稿开发。 这些活动被组织为以下特定目的： 目标1：为计划和未来的设计，行为和数据管理提供统计支持 凉亭研究此目的为初始实验设计和数据积累阶段提供了支持 拟议的和未来的馆项目。 目的2：通过凉亭研究生成的数据的铅统计分析，用于同行评审出版 该目标提供了统计支持，以分析提议的下游数据 转化研究项目和通过发展核心授予的任何试点项目。 AIM 3：在Pavilion LMIC合作网站上教育和培训调查人员有关生物统计学方法和 大规模流行病学研究所需的资源此目的提供了两个 南非和津巴布韦的早期职业生物统计学家在严格的设计中扩大区域能力 以及撒哈拉以南非洲的大规模临床和流行病学研究的可再现行为。