Data Management and Statistical Core

数据管理与统计核心

• 批准号: 10020374
• 负责人: Ying Qing Chen
• 金额: $ 16.67万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10020374
• 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; Resources; 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; 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）