Data Management and Statistical Core

数据管理与统计核心

• 批准号: 10689738
• 负责人: SAYAN DASGUPTA
• 金额: $ 33.43万
• 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/10689738
• 关键词: Address; Age; Algorithms; Appointment; Bioinformatics; Biometry; Caribbean region; Child; Clinical Data; Clinical Trials; Clinical Trials Unit; Collaborations; Colposcopy; Communicable Diseases; Data; Data Collection; Data Management Resources; Diagnosis; Dominican Republic; Dose; Enrollment; Ensure; Epidemiology; Goals; HIV; HIV/AIDS; 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; 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）将提供有效的统计计划和数据 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（C2P2）中心。 DMSC将支持 拟议的临床试验计划将跨越预防宫颈癌的连续性疫苗接种 通过治疗。临床试验将使用针对预防和治疗方法的新组合 在HIV感染的HPV相关癌症的伯恩（HIV）癌症的伯宁（HIV）癌症中，护理点和低基础设施支持 低资源环境中的人。这些试验的最终意图是将领域推进到 艾滋病毒脆弱人群中消除宫颈癌。试验1将确定新的给药时间表 为了改善HIV儿童（CLWH）的HPV疫苗接种的免疫原性。试验2将 确定新技术对筛查和分类的算法的贡献 艾滋病毒（WLWH）。试验3将评估癌前病变的非手术免疫治疗 WLWH中宫颈癌的进展。在AIM 1中，DMSC将为 三项临床试验；在AIM 2中，DMSC将提供安全的数据管理和安全监控服务； 在AIM 3中，DMSC将通过应用创新统计来推进科学的使命 分析和方法。 DMSC负责人Chen博士将与合作伙伴中心密切合作 行政和协调核心和临床试验共同主席的科学领导 有效且高质量的试验将影响拉丁美洲/加勒比海宫颈癌的预防 地区。