Maternal Fetal Medicine Network: Data Coordinating Cent*

描述(申请人提供)：1986年，国家儿童健康和人类发展研究所创建了母胎医学单位(MFMU)网络，由一些主要的学术临床中心、数据协调中心和研究所本身组成。该网络的目的是进行临床研究，以减少不良妊娠和婴儿结局的风险，最终目的是促进开展良好研究，作为产科和新生儿医学决定的基础。目前，MFMU网络正在规划、进行和分析围产期医学各个方面的随机临床试验和观察性研究，如早产预防、脑瘫预防、先兆子痫预防和分娩管理。乔治华盛顿大学生物统计中心提出了这项建议，继续作为网络的数据协调中心。我们的目的是在研究设计、研究实施和统计分析方面提供专业知识和支持。我们将在这项研究的设计中发挥统计领导作用，准备中期分析，并迅速和及时地进行最终分析。我们将编写研究文件，包括协议、操作手册和案例报告表格，并将继续提供一个全面的数据处理系统，包括分布式和中央数据输入、数据库管理和数据质量控制。我们将协助调查人员准备研究结果的手稿和摘要，并将数据存档供公众查阅。我们还将提供行政支助，例如：安排提供研究药物和实验室化验的后勤服务，维护MFMU网络网站，协调会议、培训班和结果审查。我们将有效管理资源，以便及时开展新的研究。总之，我们将作为该网络的正式成员参加，以了解和改善怀孕过程和新生儿结局为共同目标。

DESCRIPTION (provided by applicant): In 1986, the National Institute of Child Health and Human Development created the Maternal Fetal Medicine Units (MFMU) Network, consisting of a number of major academic clinical centers, a data coordinating center, and the Institute itself. The purpose of the Network was to conduct clinical research aimed at reducing the risk of adverse pregnancy and infant outcome with the ultimate purpose of contributing to the body of well conducted studies on which to base medical decisions in obstetrics and neonatology. At present the MFMU Network is planning, conducting and analyzing multiple randomized clinical trials and observational studies in various aspects of perinatal medicine such as preterm birth prevention, prevention of cerebral palsy, prevention of preeclampsia and the management of labor. The George Washington University Biostatistics Center presents this proposal to continue to serve as the data coordinating center for the Network. Our purpose is to provide expertise and support in study design, study conduct and statistical analysis. We will provide statistical leadership in the design of the study, prepare interim analyses, and perform final analyses in an expeditious and timely manner. We will prepare study documents, including protocols, manuals of operations and case report forms, and we will continue to provide a comprehensive data processing system including distributed and central data entry, data base management and data quality control. We will assist investigators in preparation of manuscripts and abstracts from study results and we will archive the data for public access. We will also provide administrative support such as: arrangement of logistical services for provision of study drugs and laboratory assays, maintenance of the MFMU Network website, coordination of meetings, training sessions and outcome reviews. We will manage resources effectively, so that we can start new studies in a timely manner. In summary, we will participate as full members of the Network with the common goal of understanding and improving the course of pregnancy and neonatal outcome.