Data Coordinating Center for the Prematurity and Respiratory Outcomes Program

早产和呼吸结果计划数据协调中心

• 批准号: 8068783
• 负责人: Barbara Schmidt
• 金额: $ 262.08万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-01 至 2015-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8068783
• 关键词: Adherence; Adopted; Biological Markers; Biometry; Breathing; Child; Childhood; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Consent Forms; Data Analyses; Data Coordinating Center; Development; Diagnostic; Documentation; Ensure; Epidemiologic Studies; Goals; Internet; Joints; Leadership; Life; Manuscripts; Modeling; Monitor; National Heart, Lung, and Blood Institute; Neonatology; Online Systems; Outcome; Participant; Pennsylvania; Performance; Premature Birth; Premature Infant; Procedures; Process; Protocols documentation; Publications; Pulmonology; Research; Research Methodology; Risk; Role; Scientist; Services; Site; Structure; System; Universities; Vulnerable Populations; abstracting; biobank; clinical epidemiology; data management; design; human subject protection; improved; medical schools; meetings; planetary Atmosphere; premature; programs; prospective; respiratory; working group

DESCRIPTION (provided by applicant): This is an application from the Division of Neonatology and the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania (Penn) School of Medicine to serve as the Data Coordinating Center (DCC) for the Prematurity and Respiratory Outcomes Program (PROP).The long-term goal of the PROP collaboration is to improve respiratory outcomes during the first year of life after preterm birth. The PROP DCC will provide scientific expertise and logistical support to the PROP collaboration for the following 5 specific aims: 1.To provide expertise in neonatology, pediatric pulmonology, biostatistics, epidemiology and clinical research methodology and to share in the scientific leadership of the PROP collaboration in developing a multicenter prospective research approach to the study of biomarkers and other diagnostic and risk models; 2.T0 develop a World Wide Web-based comprehensive data management system for up to three collaborative protocols and coordination of all multi-center PROP activities; 3. To provide comprehensive administrative support for the PROP Research Network, promoting effective communications, coordinating meetings, working groups, document development and management, and distribution of study proceedings among the network entities; 4. To provide site management services including oversight of Clinical Research Centers (CRCs) compliance with regulatory requirements and human subject protection practices, as well as monitoring performance in implementation of the protocol, providing support for and monitoring of clinical start-up procedures, answering queries, and resolving issues as they arise; 5. To develop data analysis and monitoring plans, provide statistical collaboration for the PROP manuscripts, and to provide input and support for preparing and submitting joint presentations and publications. One of the most important scientific contributions of the PROP DCC to the PROP collaboration will be to ensure that the multicenter project(s) is rigorously designed, executed and analyzed according to the highest methodological standards. (End of Abstract) RELEVANCE: More than 12% of all babies in the US are born too small and too soon. Many of these preterm infants either die or survive with long-lasting respiratory problems. The aim of this research is to better understand the breathing difficulties after preterm birth, and to help find means of reducing the heavy burden of respiratory illness in this vulnerable population of children.

描述（由申请人提供）：这是一份来自宾夕法尼亚大学医学院新生儿学部和临床流行病学和生物统计中心（CCEB）的申请，申请作为早产和呼吸结果项目（PROP）的数据协调中心（DCC）。PROP合作的长期目标是改善早产后第一年的呼吸结局。PROP DCC将为PROP合作提供科学专业知识和后勤支持，以实现以下5个具体目标：提供新生儿学、儿科肺病学、生物统计学、流行病学和临床研究方法方面的专业知识，并在PROP合作中分享科学领导地位，开发多中心前瞻性研究方法，研究生物标志物和其他诊断和风险模型；2.开发一个基于万维网的综合数据管理系统，用于多达三个协作协议和协调所有多中心PROP活动；3. 为PROP研究网络提供全面的行政支援，促进有效的沟通、协调会议、工作小组、文件编制和管理，以及在网络实体之间分发研究报告；4. 提供现场管理服务，包括监督临床研究中心（CRCs）遵守监管要求和人类受试者保护实践，以及监测方案实施的表现，为临床启动程序提供支持和监测，回答疑问，并解决出现的问题；5. 制定数据分析和监测计划，为PROP手稿提供统计合作，并为准备和提交联合报告和出版物提供投入和支持。PROP DCC对PROP合作最重要的科学贡献之一将是确保多中心项目按照最高的方法标准严格设计、执行和分析。（摘要结束）