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 (C2P2) 中心将支持该计划。 拟议的临床试验计划将涵盖疫苗接种预防宫颈癌的整个过程 临床试验将采用新的预防和治疗相结合的方法。 护理点和低基础设施支持，以解决 HIV 感染者中 HPV 相关癌症的负担 这些试验的最终目的是推动该领域向资源匮乏的地区发展。 消除艾滋病毒易感人群中的宫颈癌试验 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（CLWH）。 确定新技术对完善女性携带者筛查和分类算法的贡献 HIV (WLWH) 试验将评估非手术免疫疗法对癌前病变的中断作用。 在目标 1 中，DMSC 将为 WLWH 进展为宫颈癌提供设计和分析支持。 三项临床试验；在目标 2 中，DMSC 将提供安全数据管理和安全监测服务； 在目标 3 中，DMSC 将通过应用创新统计来推进科学使命 DMSC 领导者陈博士将与合作中心密切合作。 行政和协调核心以及临床试验联合主席的科学领导力，以发展 高效、高质量的试验将影响拉丁美洲/加勒比地区的宫颈癌预防 地区。