Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk

未产妇早产：未充分研究的高危人群

• 批准号: 8413217
• 负责人: CORETTE Breeden PARKER
• 金额: $ 88.42万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-10 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8413217
• 关键词: Advisory Committees; Attention; Back; Biological Markers; Biometry; Certification; Communication; Consent Forms; Data; Data Analyses; Data Collection; Development; Doctor of Philosophy; Enrollment; Ensure; Epidemiologic Studies; Genetic; Health; Human Resources; Individual; Institutional Review Boards; Interview; Joints; Knowledge; Leadership; Logistics; Manuals; Measurement; Medical; Methodology; Methods; Monitor; National Institute of Child Health and Human Development; Pamphlets; Paper; Patients; Perinatal Epidemiology; Phase; Physicians; Population; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Principal Investigator; Procedures; Process; Protocols documentation; Publications; Quality Control; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Risk; Running; Safety; Sample Size; Schedule; Scientist; Security; Site Visit; Study Section; System; Teleconferences; Testing; Texas; Training; Translations; Universities; Visit; Woman; Work; base; capitate bone; clinical research site; data management; experience; fetal medicine; improved; instrument; meetings; member; operation; protocol development; public health relevance; quality assurance; screening; sound; statistics; stillbirth; web site

DESCRIPTION (provided by applicant): RTI submits this application for the Data Coordinating and Analysis Center (DCAC) described in RFA-HD-08- 029 and entitled "Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk." The DCAC is led by Corette Parker, DrPH, PI, and Matthew Koch, MD, PhD, Co-PI, senior biostatisticians, who have assembled a core team with expertise in biostatistics, statistical genetics, perinatal epidemiology, maternal-fetal medicine, pregnancy outcomes and measurements, data management and project coordination. The team is drawn from the statistics and epidemiology and research computing division units at RTI and complimented by two distinguished consultants, Gordon CS Smith, MD, PhD of Cambridge University, and Radek Bukowski, MD, PhD of the University of Texas Medical Branch at Galveston. This core team brings unique strength to the challenges and successful operation of the DCAC and the Network as a whole. Most of the team members work together on the NICHD Stillbirth Collaborative Research Network. This experience provides a joint understanding ofthe complexities ofthe proposed study. Drs. Parker and Koch each have 20+ years of experience managing DCAC activities and leading statistical tasks for multisite studies. They will supplement the core team with other individuals, as appropriate, from RTI's ample and diverse research staff to bring the most appropriate mix of expertise to each phase of the research. The proposed team will establish a partnership with the NICHD staff and Clinical Site Investigators to develop and implement common protocols to study nulliparous women and to acquire and analyze the resulting data to identify biomarkers and understand the mechanism and prediction of preterm birth and other adverse pregnancy outcomes. The DCAC responsibilities will include (1) providing leadership in biostatistics and data management; (2) implementing a communications infrastructure and providing logistics support; (3) participating in protocol development, including data collection instruments, manuals of operation, and other study materials; (4) implementing data collection and management systems; (5) assisting in training personnel in standard study procedures; (6) assisting in development of QA/QC procedures, (7) producing routine and ad hoc reports for clinical sites, NICHD, the Steering Committee, and the Advisory and Safety Monitoring Committee; and (8) disseminating study results through publications and presentations. The project coordinator will be located at RTI's office in Rockville, MD adjacent to NICHD for convenience.

描述（由申请人提供）：RTI 向数据协调和分析中心 (DCAC) 提交了这份申请，在 RFA-HD-08-029 中进行了描述，标题为“未产妇早产：处于高风险中的未充分研究人群”。 DCAC 由高级生物统计学家 Corette Parker 博士、PI 和 Matthew Koch 医学博士、哲学博士、Co-PI 领导，他们组建了一支在生物统计学、统计遗传学、围产期流行病学、母胎医学、妊娠结局和测量、数据管理和项目协调方面拥有专业知识的核心团队。该团队由 RTI 的统计、流行病学和研究计算部门组成，并得到了两位杰出顾问的称赞：剑桥大学的 Gordon CS Smith 医学博士和加尔维斯顿德克萨斯大学医学分院的 Radek Bukowski 医学博士和哲学博士。这个核心团队为 DCAC 和整个网络的挑战和成功运营带来了独特的力量。大多数团队成员在 NICHD 死产合作研究网络上共同工作。这一经验使人们对拟议研究的复杂性有了共同的理解。博士。 Parker 和 Koch 各自拥有 20 多年管理 DCAC 活动和领导多站点研究统计任务的经验。他们将酌情从 RTI 充足且多样化的研究人员中招募其他人员来补充核心团队，从而为研究的每个阶段带来最合适的专业知识组合。拟议的团队将与 NICHD 工作人员和临床现场研究人员建立合作伙伴关系，制定和实施共同协议来研究未产妇，获取和分析结果数据，以确定生物标志物并了解早产和其他不良妊娠结局的机制和预测。 DCAC 的职责包括 (1) 在生物统计和数据管理方面提供领导； （二）建设通讯基础设施并提供后勤保障； (3) 参与方案制定，包括数据采集仪器、操作手册和其他研究材料； （四）实施数据收集和管理制度； （五）协助培训人员标准学习程序； (6) 协助制定 QA/QC 程序，(7) 为临床中心、NICHD、指导委员会以及咨询和安全监测委员会制作常规和临时报告； (8) 通过出版物和演示传播研究结果。为方便起见，项目协调员将驻扎在马里兰州罗克维尔的 RTI 办公室，毗邻 NICHD。