CAMPO Data Management and Statistical Core

CAMPO 数据管理和统计核心

基本信息

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
项目类别：
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

项目摘要

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.

加州-墨西哥-波多黎各 (CAMPO) 联盟将进行三项临床研究研究 1 的重点是预防墨西哥和波多黎各艾滋病毒阳性妇女的宫颈癌。将在 4000 年检查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女性研究 2 将评估使用肛门生殖器益生菌对健康的影响。 600 名 HIV 阳性女性和男性的肛门和宫颈微生物群特征及其与肛门和宫颈 HSIL 消退的关系，以及无病变人群中高危 HPV DNA 持久性的降低。研究 3 将评估基于多价复制缺陷型腺病毒的安全性和有效性 HPV 疫苗可治疗 300 名 HIV 阳性女性和男性的宫颈和治疗性肛门 HSIL，并确定免疫反应与 HSIL 回归相关。中心实验室核心和临床试验计划、数据管理和统计核心 (DMSC) 具有以下目标：（1）以严谨的研究设计方法支持临床试验计划， (2)提供数据管理、数据采集和有效满足临床试验计划和核心需求的质量保证体系；以及 (3) 通过提供培训和指导支持早期职业调查员的职业发展与所有 CAMPO 核心一样，CAMPO 应用于生物统计学、生物信息学和临床研究设计。 DMSC 将由 CAMPO 联盟站点之一的教员领导，其他两个站点的联合领导者也将共同领导。 UPR 的 Suárez 博士将领导 DMSC，INSP 的 Hector Lamadrid 博士和 UCSF 的张莉博士将担任联合领导。 DMSC 将提供虚拟和物理基础设施来支持 CAMPO 联盟。生物统计学、生物信息学和数据管理领域的临床试验计划。坚持高质量的研究设计和严格的统计方法，DMSC 将在从研究设计、收集数据分析到结果传播的每个阶段。在 DMSC 的监督下，Emmes 公司将为研究和生物样本数据的收集、管理和质量保证。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认识职业调查员，有专门的专家可以支持临床中更复杂的分析试验计划。