Data Management & Statistical Core

项目总结-数据管理和统计核心 数据管理和统计核心(DMSc)的总体目标是伙伴关系评估病毒和 为艾滋病毒携带者提供免疫景观与肿瘤学交叉(展馆)将提供 全面的统计设计、数据管理和分析，以支持进行严格和 展馆调查人员进行的可重复研究，他们正在努力了解 可归因于人类乳头瘤病毒(HPV)和Epstein-Barr病毒的肿瘤比例 (EBV)在撒哈拉以南非洲的艾滋病毒携带者中，包括罕见的肿瘤类型，如肛门，宫颈， 结膜癌、口咽癌、阴道癌和外阴癌。DMSC将由Michael Schell博士领导，他是 在临床和流行病学研究的设计、分析和管理方面具有卓越的资质。这个 DMSc设计了一个强大而灵活的管道，该管道建立在广泛的基础设施和长期 展馆与包括HIM1在内的调查人员合作建立的国际合作， BROADEN2和EVRI3国际研究小组。它利用了莫菲特癌症中心的广泛投资 在生物统计学、生物信息学、信息学和计算能力以及专业知识的深度和广度方面 分析基础、转译、临床和大规模癌症流行病学研究以解决项目 StellenBosch大学(南非)和津巴布韦大学的目标和生物统计能力建设 展馆低收入和中等收入国家(LMIC)网站。此外，DMSC将提供教育和培训 通过向成员和研究人员提供生物统计学方面的讲座和指导，目标是建立 LIMC合作伙伴网站的专业知识和能力，以领导未来的研究/试验。为了实现这一总体目标， DMSc将提供统计和分析设计、样本量确定、持续监测 为同行评议的出版物积累数据、统计分析结果和编写手稿。 这些活动的具体目标如下： 目标1：为规划和未来的设计、实施和数据管理提供统计支持 Pavilion研究这一目标为初始实验设计和数据积累阶段提供支持 对拟议和未来的展馆项目进行评估。 目标2：对Pavilion研究产生的数据进行牵头统计分析，供同行评议的出版物使用 这一目标为分析拟议的 翻译研究项目和通过开发核心授予的任何试点项目。 目标3：在展馆LMIC合作地点对调查人员进行生物统计学方法和 大规模流行病学研究所需的资源这一目标提供了两个人的实践指导 南非和津巴布韦早期职业生物统计员在严谨的设计中扩大区域能力 在撒哈拉以南非洲进行广泛的临床和流行病学研究，并可重复进行。

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.