CAMPO Data Management and Statistical Core

CAMPO 数据管理和统计核心

• 批准号: 10469359
• 负责人: Li Zhang
• 金额: $ 15.42万
• 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 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10469359
• 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

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 HIVpositive 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 CoLeaders. 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.

加利福尼亚 - 墨西哥 - 普洛托Rico（Campo）财团将进行三项临床研究 专注于预防墨西哥和波多黎各的HIV阳性女性宫颈癌。研究1 将检查4000中宫颈高级鳞状上皮内病变（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将评估肛门生物益生菌对 肛门和宫颈微生物群的谱以及与无病变患者的600名HIVPSISTIS效率男性和男性的肛门和宫颈HSIL回归的关系以及降低高风险HPV DNA持久性。 研究3将评估基于多价复制缺陷型腺病毒的安全性和效率 治疗性HPV疫苗可在300名HIV阳性男性和男性中治疗宫颈和肛门HSIL并鉴定 HSIL回归的免疫反应相关。与行政和协调核心合作， 中央实验室核心与临床试验计划，数据管理和统计核心（DMSC） 具有以下目的：（1）在研究设计中使用严格的方法支持临床试验计划， 数据分析和研究结果的传播； （2）提供数据管理，数据收集和 有效地满足临床试验计划和核心需求的质量保证系统； （3）到 通过提供培训和心态来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。与所有坎波核心一样，坎波 DMSC将由Campo财团之一的教师领导，其他两个地点的共同领导者将领导。 UPR的Suárez博士将带领DMSC，博士。 Insp的Hector Lamadrid和UCSF的Li Zhang作为coleaders。 DMSC将提供虚拟和物理基础架构，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。确保 遵守高质量研究设计和严格的统计方法，DMSC将在 每个阶段，从研究设计，分析收集的数据以及结果传播。在 对DMSC的监督，Emmes Corporation将为安全，可扩展和用户友好的平台提供 研究和生物测量数据的收集，管理和质量保证。创建DMSC作为一个 共享资源将培养新兴技能，并对早期的基本生物统计分析表示赞赏 职业调查人员，专门的专家可用于支持临床中更复杂的分析 试验计划。