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

描述（由申请人提供）：RTI向RFA-HD-08- 029中描述的数据协调和分析中心（DCAC）提交了这份申请，标题为“未生育妇女的早产：一个未充分研究的高风险人群”。DCAC由高级生物统计学家Corette Parker博士和Matthew Koch博士领导，他们组建了一个在生物统计学、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具有专业知识的核心团队。该团队来自RTI的统计、流行病学和研究计算部门，并得到了两位杰出顾问的称赞，他们是剑桥大学的Gordon CS Smith医学博士和加尔维斯顿德克萨斯大学医学分部的Radek Bukowski医学博士。这个核心团队为DCAC和整个网络的挑战和成功运作带来了独特的优势。大多数团队成员在NICHD死产合作研究网络上一起工作。这一经验提供了对拟议研究的复杂性的共同理解。Drs。Parker和Koch都有20多年管理DCAC活动和领导多地点研究统计任务的经验。他们将从RTI丰富多样的研究人员中适当地补充核心团队，为研究的每个阶段带来最合适的专业知识组合。该团队将与NICHD的工作人员和临床现场调查员建立合作关系，制定和实施共同的方案来研究未生育妇女，并获取和分析结果数据，以确定生物标志物，了解早产和其他不良妊娠结局的机制和预测。DCAC的职责将包括(1)在生物统计学和数据管理方面提供领导；(2)实施通信基础设施并提供后勤保障；(3)参与方案的制定，包括数据采集仪器、操作手册和其他研究资料；（四）实施数据收集和管理制度；（五）协助培训人员学习标准程序；(6)协助制定质量保证/质量控制程序；(7)为临床站点、NICHD、指导委员会以及咨询和安全监测委员会编写常规和临时报告；(8)通过出版物和报告传播研究成果。为方便起见，项目协调员将设在RTI位于马里兰州Rockville的办公室，毗邻NICHD。

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.