Pelvic Floor Disorders Network Data Coordinating Center (U01)

盆底疾病网络数据协调中心 (U01)

• 批准号: 8699240
• 负责人: MARIE G GANTZ
• 金额: $ 388.39万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-08 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8699240
• 关键词: Address; Adverse event; Behavioral; Biocompatible Materials; Biometry; Caring; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Communication; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Files; Data Quality; Development; Diagnosis; Enrollment; Ensure; Leadership; Mission; Monitor; National Institute of Child Health and Human Development; North Carolina; Observational Study; Online Systems; Operative Surgical Procedures; Outcome; Outcome Measure; Patient Outcomes Assessments; Pelvic Floor Disorders; Pelvic floor structure; Preparation; Prevention; Principal Investigator; Productivity; Program Evaluation; Protocols documentation; Publications; Quality of life; Reporting; Research; Research Design; Research Personnel; Resolution; Running; Safety; Services; Site; Solutions; Specimen Handling; Surveys; System; Time; United States National Institutes of Health; Universities; Woman; clinical research site; cost effectiveness; data management; design; distributed data; experience; flexibility; improved; innovation; meetings; multidisciplinary; tool

DESCRIPTION (provided by applicant): RTl proposes to serve as the data coordinating center (DCC) for the NICHD Pelvic Floor Disorders Network (PFDN), in support of its mission to improve the care of women with pelvic floor disorders (PFDs) by conducting well-designed, adequately powered studies of diagnosis, prevention, and treatment. We will draw upon our 35 years of experience as a DCC supporting multicenter NIH clinical research networks to provide the Network statistical leadership in study design and data analysis and operational support through data management and logistical services. Specifically, we will (1) collaborate in developing, implementing, and monitoring Network protocols; (2) provide data management, including preparation of public data files; (3) prepare data and safety reports for the Data Safety Monitoring Board and Network committees; (4) collaborate in the analysis of data and publication of results of Network studies; (5) coordinate acquisition of study materials and biological specimen processing; and (6) provide all other logistical support, including Network meetings and communication necessary to run an efficient and productive Network. This application has specific strengths that will enhance the scientific productivity of the PFDN: (1) Scientific leadership of Dr. Dennis Wallace, with more than 18 years experience as a senior clinical biostatistician and Principal Investigator for multisite NIH research networks. (2) Multidisciplinary experts, from RTl and The University of North Carolina, Chapel Hill (UNC), in biostatistics; surgical, behavioral, and quality of life outcomes; cost-effectiveness and program evaluation; and qualitative and quantitative surveys, who will collaborate with PFDN investigators to (a) develop innovative trial designs (conducting formative research for methodological advancements if needed) to address the unique problems in pelvic floor trials; (b) develop and implement new outcome measures; (c) leverage trial data with well-designed secondary observational studies that answer important ancillary questions; and (d) respond quickly to fluctuations in Network analytic needs. (3) A state-of-the art, flexible, and comprehensive web-based distributed data entry and management system that will (a) ensure high-quality data with rapid error resolution and real-time enrollment and adverse event monitoring; (b) provide creative solutions to difficult problems, like collecting patient-reported outcomes; and (c) provide site staff with study management and reporting tools that enhance the scientific quality and efficiency of clinical site trial activities. RELEVANCE: The PFDN was established in 2001 to improve the care of women with PFDs by conducting well-designed, rigorous clinical trials and studies of diagnosis, prevention, and treatment. A DCC provides essential biostatistical and clinical trials expertise to such a productive multicenter research enterprise and ensures standardized study design and development, and data collection and analyses, using independent statistical expertise to formulate, design, monitor, and analyze RCTs and provides communications and logistical support between the disparate clinical sites to optimize the efficiency and productivity of the Network.

描述（由申请人提供）：RTL提议作为NICHD骨盆底疾病网络（PFDN）的数据协调中心（DCC），以支持其通过进行骨盆底障碍（PFD）（PFD）女性的护理，通过进行良好设计，精心设计，充分发挥诊断的诊断，诊断和治疗。我们将借鉴我们35年的DCC经验，支持多中心NIH临床研究网络，以通过数据管理和后勤服务在研究设计和数据分析和运营支持方面提供网络统计领导力。具体来说，我们将（1）合作开发，实施和监视网络协议； （2）提供数据管理，包括准备公共数据文件； （3）为数据安全监控委员会和网络委员会准备数据和安全报告； （4）在数据分析和网络研究结果的分析中进行合作； （5）协调研究材料和生物标本加工的获取； （6）提供所有其他后勤支持，包括网络会议和运行高效和生产性网络所必需的沟通。该应用程序具有特定的优势，可以提高PFDN的科学生产力：（1）Dennis Wallace博士的科学领导力，拥有18年以上的经验，是高级临床生物统计学家和多站点NIH研究网络的首席研究员。 （2）生物统计学的RTL和北卡罗来纳大学教堂山（UNC）的多学科专家；外科手术，行为和生活质量；成本效益和计划评估；以及定性和定量调查，他们将与PFDN研究人员合作（a）开发创新的试验设计（如果需要的话，进行方法论进步进行形成性研究），以解决骨盆落地试验中的独特问题； （b）制定和实施新的结果指标； （c）利用精心设计的二级观察研究来利用试验数据，回答重要的辅助问题； （d）对网络分析需求的波动迅速响应。 （3）最先进的，灵活的，全面的基于Web的分布式数据输入和管理系统，该系统将（a）确保具有快速误差和实时注册和不良事件监视的高质量数据； （b）为困难问题提供创造性的解决方案，例如收集患者报告的结果； （c）为现场人员提供研究管理和报告工具，以提高临床现场试验活动的科学质量和效率。 相关性：PFDN成立于2001年，目的是通过进行精心设计，严格的临床试验以及对诊断，预防和治疗的研究来改善PFD女性的护理。 DCC为这种生产性的多中心研究企业提供了必不可少的生物统计和临床试验专业知识，并确保使用独立的统计专业知识来确保标准化的研究设计和开发以及数据收集和分析，以建立，设计，监视和分析RCT，并提供RCT，并在分散的临床站点之间提供沟通和逻辑支持，以优化网络的效率和生产力。