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 数据管理和统计核心（DMSC）的总体目标是评估病毒和 免疫景观与艾滋病毒感染者肿瘤学交叉点（PAVILION）将提供 全面的统计设计，数据管理和分析，以支持进行严格的， PAVILION研究人员的可重复研究，他们正在努力在理解 病因可归因于人乳头瘤病毒（HPV）和EB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， 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，分析和管理方面具有特殊资格。的 DMSC设计了一个强大而灵活的管道，建立在广泛的基础设施和长期 由PAVILION合作研究者建立的国际合作，包括HIM 1， BROADEN 2和EVRI 3国际研究团队。它利用了莫菲特癌症中心的广泛投资， 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 在分析基础、转化、临床和大规模癌症流行病学研究中， 在斯泰伦博斯大学（南非）和津巴布韦大学， PAVILION低收入和中等收入国家（LMIC）研究中心。此外，灾害管理服务中心将提供教育和培训， 通过为成员和研究人员举办生物统计学讲座和提供指导， LIMC合作研究中心领导未来研究/试验的专业知识和能力。为了实现总体目标， DMSC将提供统计和分析设计、样本大小确定、 积累数据，对结果进行统计分析，并为同行评审的出版物开发手稿。 这些活动的具体目标如下： 目标1：为计划和未来的项目的设计、实施和数据管理提供统计支持 PAVILION研究该目标为初始实验设计和数据积累阶段提供支持 未来和未来的项目。 目标2：领导对PAVILION研究产生的数据进行统计分析，以供同行评审发表 这一目标为分析拟议的 翻译研究项目和通过发展核心授予的任何试点项目。 目标3：对PAVILION LMIC合作研究中心的研究人员进行生物统计方法方面的教育和培训， 大规模流行病学研究所需的资源 南非和津巴布韦的早期职业生物统计学家，以扩大严格设计的区域能力， 在撒哈拉以南非洲进行大规模的临床和流行病学研究。