CAMPO Data Management and Statistical Core

数据管理和统计核心摘要 加利福尼亚-墨西哥-波多黎各（CAMPO）联盟将进行三项临床研究 重点是在墨西哥和波多黎各预防艾滋病毒阳性妇女的宫颈癌。研究1 将在4000年检查宫颈高度鳞状上皮内病变（HSIL）的新筛查算法 墨西哥和波多黎各的艾滋病毒阳性妇女。研究2将评估肛门生殖器益生菌使用对 肛门和宫颈微生物群特征以及与600例HIV感染者肛门和宫颈HSIL消退的关系- 阳性的女性和男性以及没有病变的人中高危HPV DNA持续性的降低。 研究3将评估多价复制缺陷型腺病毒为基础的安全性和有效性。 治疗性HPV疫苗治疗300名HIV阳性女性和男性的宫颈和肛门HSIL， 免疫应答与HSIL消退相关。与行政和协调核心合作， 中心实验室核心和临床试验项目，数据管理和统计核心（DMSC） 有以下目的：（1）支持临床试验计划，在研究设计中采用严格的方法， 数据分析和传播研究结果;（2）提供数据管理、数据收集和 质量保证体系，以有效满足临床试验项目和核心的需求;以及（3） 通过提供培训和辅导，支持早期职业调查员的职业发展 生物统计学、生物信息学和临床研究设计。与所有CAMPO核心一样，CAMPO DMSC将由CAMPO联盟网站之一的教师领导，其他两个网站的共同领导人。 博士UPR的Suárez将领导DMSC，INSP的Hector Lamadrid博士和UCSF的Li Zhang博士将担任联合主席。 领导人的人选信号DMSC将提供虚拟和物理基础设施，以支持CAMPO联盟的 生物统计学、生物信息学和数据管理领域的临床试验计划。确保 遵循高质量的研究设计和严格的统计方法，DMSC将提供输入， 每个阶段，从研究设计，收集数据的分析和结果的传播。下工作 在DMSC的监督下，埃姆斯公司将提供一个安全、可扩展和用户友好的平台， 研究和生物标本数据的收集、管理和质量保证。建立灾害管理服务中心， 共享资源将培养早期儿童的新兴技能和对基本生物统计分析的理解。 职业调查员，配备专门的专家，以支持临床领域内更复杂的分析 审判程序。

ABSTRACT FOR THE DATA MANAGEMENT AND STATISTICAL CORE The California-Mexico-Puerto Rico (CAMPO) Consortium will perform three clinical research studies focused on the prevention of cervical cancer among HIV-positive women in Mexico and Puerto Rico. Study 1 will examine new screening algorithms for cervical high-grade squamous intraepithelial lesions (HSIL) in 4000 HIV-positive women in Mexico and Puerto Rico. Study 2 will evaluate the impact of anogenital probiotic use on anal and cervical microbiota profiles and the relationship to anal and cervical HSIL regression in 600 HIV- positive women and men as well as reduction of high-risk HPV DNA persistence among those with no lesions. Study 3 will evaluate the safety and efficacy of a multivalent replication-defective adenovirus-based therapeutic HPV vaccine to treat cervical and anal HSIL in 300 HIV-positive women and men and identify immune response correlates of HSIL regression. Working with the Administrative and Coordinating Core, the Central Laboratory Core and the Clinical Trials Program, the Data Management and Statistical Core (DMSC) has the following aims: (1) to support the Clinical Trials Program with rigorous methodology in study design, data analysis and dissemination of research findings; (2) to provide data management, data collection and quality assurance systems to efficiently meet the needs of the Clinical Trials Program and the Cores; and (3) to support the career development of early career investigators through the provision of training and mentorship in biostatistics, bioinformatics and clinical research study design. As with all CAMPO Cores, the CAMPO DMSC will be led by faculty at one of the CAMPO Consortium sites, with Co-Leaders from the other two sites. Dr. Suárez of UPR will lead the DMSC, with Drs. Hector Lamadrid of INSP and Li Zhang of UCSF as Co- Leaders. The DMSC will provide both virtual and a physical infrastructure to support the CAMPO Consortium’s Clinical Trials Program in the areas of biostatistics, bioinformatics, and data management. To ensure adherence to high quality study design and rigorous statistical methodology, the DMSC will provide input at every stage, from study design, analysis of collected data, and dissemination of results. Working under the supervision of the DMSC, the Emmes Corporation will provide a secure, scalable, and user-friendly platform for the collection, management, and quality assurance of study and biospecimen data. Creation of the DMSC as a shared resource will foster emerging skills and an appreciation of basic biostatistical analysis among early career investigators, with dedicated experts available to support more complex analyses within the Clinical Trials Program.