Data Management and Statistical Core

数据管理与统计核心

基本信息

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
项目类别：
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

项目摘要

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。