Data Management and Statistical Core

数据管理与统计核心

• 批准号: 10470119
• 负责人: Ying Qing Chen
• 金额: $ 7.1万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-18 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10470119
• 关键词: AIDS/HIV problem; Address; Age; Algorithms; Appointment; Bioinformatics; Biometry; Caribbean region; Child; Clinical Data; Clinical Trials; Clinical Trials Unit; Colposcopy; Communicable Diseases; Data; Data Collection; Data Management Resources; Diagnosis; Dominican Republic; Dose; Enrollment; Ensure; Epidemiology; Goals; HIV; Health Sciences; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Immune; Immunotherapy; Individual; Information Dissemination; Infrastructure; International; Interruption; Latin America; Leadership; Lesion; Location; Malignant neoplasm of cervix uteri; Methods; Mission; Monitor; Operative Surgical Procedures; Pap smear; Papillomavirus Transforming Protein E6; Persons; Peru; Physical environment; Play; Politics; Prevention; Prevention Research; Preventive Medicine; Public Health; Publications; Reporting; Research; Resource-limited setting; Role; Safety; Schedule; Science; Scientific Advances and Accomplishments; Secure; Security; Services; Sirolimus; Statistical Data Interpretation; Statistical Methods; Testing; Time; Triage; Universities; Vaccination; Vaccines; Visual; Vulnerable Populations; Washington; Woman; Work; Youth; automated visual evaluation; cancer prevention; cervical cancer prevention; clinical center; clinical database; co-clinical trial; collaborative environment; data management; design; electronic data; flexibility; immunogenicity; improved; innovation; member; new technology; point of care; premalignant; primary endpoint; professor; programs; response; screening; secondary endpoint; standard of care; statistical center; tool; treatment strategy; trial design

PROJECT SUMMARY - DATA MANAGEMENT AND STATISTICAL CORE (DMSC) The Data Management and Statistical Core (DMSC) will provide effective statistical planning and data management support to optimize the successful accomplishment of the scientific aims of the Cervical Cancer Prevention Partnership (C2P2) Center in Peru and the Dominican Republic. The DMSC will support the proposed Clinical Trials Program that will span the continuum of cervical cancer prevention from vaccination through treatment. The clinical trials will use a new combination of prevention and treatment methods aimed at point-of-care and low-infrastructure support to address the burden of HPV-related cancers in HIV-infected persons in low-resource settings. The ultimate intent of these trials is to advance the field toward the elimination of cervical cancer among vulnerable populations with HIV. Trial 1 will identify new dosing schedules to improve the immunogenicity of HPV vaccination among children living with HIV (CLWH). Trial 2 will ascertain the contribution of new technologies to refine algorithms for screening and triage of women living with HIV (WLWH). Trial 3 will assess non-surgical immune-based treatments of precancerous lesions to interrupt progression to cervical cancer in WLWH. In Aim 1, the DMSC will provide design and analysis support for the three clinical trials; in Aim 2 the DMSC will provide secure data management and safety monitoring services; and in Aim 3 the DMSC will advance the mission of the science through the application of innovative statistical analysis and methods. The DMSC leader Dr. Chen will collaborate closely with the Partnership Center’s scientific leadership in the Administrative and Coordinating Core and Clinical Trial Co-Chairs to develop efficient and high-quality trials that will impact the prevention of cervical cancer in the Latin America/Caribbean region.

项目摘要-数据管理和统计核心（DMSC） 数据管理和统计核心（DMSC）将提供有效的统计规划和数据 管理支持，以优化宫颈癌科学目标的成功实现 秘鲁和多米尼加共和国的预防伙伴关系中心。DMSC将支持 拟议的临床试验计划，将跨越预防宫颈癌的疫苗接种的连续性 通过治疗。临床试验将使用一种新的预防和治疗方法， 护理点和低基础设施支持，以解决艾滋病毒感染者中HPV相关癌症的负担 低资源环境中的人。这些试验的最终目的是将该领域推向 在感染艾滋病毒的弱势群体中消除宫颈癌。试验1将确定新的给药方案 提高HIV感染儿童HPV疫苗接种的免疫原性。试验2将 确定新技术对完善妇女艾滋病筛查和分诊算法的贡献 艾滋病毒（WLWH）。试验3将评估癌前病变的非手术免疫治疗， 在WLWH中进展为宫颈癌。在目标1中，灾害管理支助中心将为 三项临床试验;在目标2中，DMSC将提供安全的数据管理和安全监测服务; 在目标3中，DMSC将通过应用创新的统计方法来推进科学的使命 分析和方法。DMSC领导人陈博士将与伙伴关系中心的 在管理和协调核心和临床试验联合主席中发挥科学领导作用， 将影响拉丁美洲/加勒比地区宫颈癌预防的高效和高质量试验 地区