CAMPO Data Management and Statistical Core

CAMPO 数据管理和统计核心

• 批准号: 10226226
• 负责人: Li Zhang
• 金额: $ 13.44万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-12 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10226226
• 关键词: Adenoviruses; Adherence; Algorithms; Anus; Area; Basic Science; Bioinformatics; Biometry; California; Cervical; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Design; Collaborations; Collection; Complex Analysis; Consultations; DNA; Data; Data Analyses; Data Collection; Discipline; Ensure; Faculty; Fostering; Funding; Goals; HIV; HIV Seropositivity; HPV-High Risk; Human Papilloma Virus-Related Malignant Neoplasm; Immune response; Information Dissemination; Infrastructure; Laboratories; Latin America; Lead; Leadership; Lesion; Mentorship; Methodology; Mexico; Population; Prevention; Probiotics; Protocols documentation; Publications; Puerto Rico; Reporting; Research; Research Design; Research Personnel; Research Training; Resource Sharing; Resources; Safety; Secure; Ships; Site; Squamous intraepithelial lesion; Statistical Data Interpretation; Supervision; System; Time; Training; Training Support; Translational Research; Woman; Work; base; career; career development; cervical cancer prevention; cost; data dissemination; data management; data quality; design; men; microbiota profiles; programs; quality assurance; research data dissemination; research study; sample collection; screening; skills; statistics; success; therapeutic HPV vaccine; user-friendly; virtual

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.

摘要为数据管理和统计核心 加州-墨西哥-波多黎各(坎波)联盟将进行三项临床研究 重点关注在墨西哥和波多黎各艾滋病毒阳性妇女中预防宫颈癌。研究1 将在4000年中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将评估使用肛门益生菌对 600例HIV感染者的肛门和宫颈微生物区系及其与肛门和宫颈HSIL消退的关系 阳性的女性和男性，以及那些没有损伤的人中高危HPV DNA持久性的减少。 研究3将评估以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例HIV阳性男女宫颈和肛门HSIL 免疫应答与HSIL回归相关。与行政和协调核心合作， 中心实验室核心和临床试验计划，数据管理和统计核心(DMSc) 有以下目标：(1)在研究设计上以严格的方法学支持临床试验计划， 数据分析和研究结果的传播；(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计划和核心的需要；和(3) 通过提供培训和指导，支持早期职业调查员的职业发展 在生物统计学、生物信息学和临床研究中的研究设计。与所有坎波核心一样，坎波 DMSc将由Campo财团其中一个地点的教职员工领导，其他两个地点的联合领导人。 UPR的苏亚雷斯博士将领导DMSC，INSP的赫克托·拉马德里德博士和加州大学旧金山分校的张丽博士将共同领导DMSC。 领袖们。DMSc将提供虚拟和物理基础设施，以支持Campo财团的 生物统计学、生物信息学和数据管理领域的临床试验计划。为了确保 坚持高质量的研究设计和严格的统计方法，DMSC将在 每个阶段，从研究设计、收集的数据分析到结果的传播。在以下情况下工作 在DMSc的监督下，Emmes Corporation将提供一个安全、可扩展和用户友好的平台 研究和生物样品数据的收集、管理和质量保证。将DMSc创建为 共享资源将培养初学者的新兴技能和对基础生物统计分析的欣赏 职业调查员，有专门的专家在临床上支持更复杂的分析 试验计划。