Pelvic Floor Disorders Network Data Coordinating Center: (2016-2021)

盆底疾病网络数据协调中心：（2016-2021）

• 批准号: 10004349
• 负责人: MARIE G GANTZ
• 金额: $ 9.92万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10004349
• 关键词: Address; Back; Biological Transport; Biometry; Caring; Case Report Form; Child; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collection; Communication; Communication Tools; Custom; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Files; Data Reporting; Data Set; Decision Making; Diagnosis; Enrollment; Ensure; Equipment; Equipment and Supplies; Fecal Incontinence; Genetic; Genomics; Goals; Informatics; Infrastructure; Instruction; Leadership; Letters; Library Materials; Life; Logistics; Manuals; Manuscripts; Methodology; Mission; Monitor; National Institute of Child Health and Human Development; North Carolina; Observational Study; Online Systems; Outcome; Outcome Measure; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Pelvic Floor Disorders; Persons; Pharmaceutical Preparations; Placebos; Preparation; Prevention; Principal Investigator; Privatization; Procedures; Productivity; Program Evaluation; Proteomics; Protocols documentation; Psychometrics; Publications; Quality of life; Reporting; Research; Research Design; Research Personnel; Resolution; Running; Safety; Scientific Advances and Accomplishments; Services; Specimen; Statistical Data Interpretation; System; Technology; Teleconferences; Time; Training; Universities; Urinary Incontinence; Woman; Women' s Health; Work; base; bench to bedside; clinical research site; cost effectiveness; data management; data quality; design; electronic data; electronic data capture system; experience; follow-up; genome wide association study; health economics; improved; improved outcome; innovation; journal article; meetings; mobile computing; multidisciplinary; operation; payment; pelvic organ prolapse; quality assurance; research study; tool; translational study; trial design; web site; web-based tool; webinar

PROJECT SUMMARY (See instructions): RTI proposes to continue 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 multicenter observational studies and clinical trials to inform diagnosis, prevention, and treatment. We will build on our work as DCC in the current PFDN cycle to provide the Network with 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 reports including safety reports for the Data and Safety Monitoring Board; (4) collaborate in the analysis of data and publication of study results; (5) coordinate manufacturing of study drugs and placebos, acquisition of study equipment and materials, and collection and transport of biological specimens; and (6) provide all other support, including management of capitation payments to clinical sites, and logistical coordination of meetings and communications necessary to run an efficient and productive Network. This application has specific strengths that will enhance the scientific productivity of the PFDN: (1) Continuity of DCC leadership with Dr. Marie Gantz as Principal Investigator (PI) and Dr. Dennis Wallace as Alternate PI overseeing a DCC team experienced in PFD research, including studies of pelvic organ prolapse, urinary incontinence, and fecal incontinence. (2) Multidisciplinary experts, from RTI and The University of North Carolina, Chapel Hill, in biostatistics, statistical genetics, clinical and quality of life outcomes, cost-effectiveness, program evaluation, and clinical PFD care, who will collaborate with PFDN investigators to (a) develop innovative trial designs including bench-to-bedside translational studies; (b) develop new outcome measures to fill current gaps, particularly for outcomes patients consider crucial; and (c) respond quickly to fluctuations in Network analytic needs. (3) State-of-the-art data collection systems including (a) a web-based clinical electronic data capture and management system with rapid error resolution and real-time reports and data monitoring tools; (b) advancements in the collection of high-quality patient-reported outcome data using mobile technology; and (c) automated reports to provide daily tracking of study enrollment and progress to enhance the scientific quality and efficiency of clinical site trial activities. RELEVANCE (See instructions): The PFDN was established in 2001 to improve the care of women with PFDs by conducting well-designed multicenter observational studies and clinical trials to inform diagnosis, prevention, and treatment. A qualified, experienced DCC is critical in helping the PFDN optimize research productivity through effective study design, implementation, data collection, quality assurance, monitoring, and statistical analysis. RTI will continue to provide multidisciplinary expertise to support high-impact collaborative clinical research studies and provide communications and logistical support to optimize the efficiency and productivity of the Network.

项目总结（见说明）： RTI建议继续担任NICHD骨盆底的数据协调中心（DCC） 疾病网络（PFDN），以支持其使命，改善对患有骨盆底疾病的妇女的护理 （PFDs）通过进行精心设计的多中心观察性研究和临床试验来告知诊断， 预防和治疗。我们将在目前的和平部队发展网周期中作为发展协调委员会开展工作的基础上， 在研究设计、数据分析和通过数据提供业务支持方面具有统计领导力的网络 管理和后勤服务。具体而言，我们将（1）在开发、实施和 监测网络协议;（2）提供数据管理，包括编制公共数据文件;（3） 为数据和安全监测委员会准备报告，包括安全报告;（4）在 数据分析和研究结果的发表;（5）协调研究药物和安慰剂的生产， 研究设备和材料的获取，生物标本的采集和运输;（六） 提供所有其他支持，包括管理对临床研究中心的按人头付费，以及后勤支持 协调必要的会议和通信，以有效和富有成效地运行网络。 该应用程序具有特定的优势，将提高PFDN的科学生产力： (1)DCC领导层的连续性，玛丽兹博士作为主要研究者（PI），丹尼斯华莱士博士 作为候补PI，监督具有PFD研究经验的DCC团队，包括盆腔器官研究 脱垂、尿失禁和大便失禁。 (2)来自RTI和查佩尔山的北卡罗来纳州大学的生物统计学多学科专家， 统计遗传学、临床和生活质量结局、成本效益、项目评估和临床 PFD护理，将与PFDN研究者合作，（a）开发创新试验设计，包括 从实验室到床边的转化研究;（B）开发新的结果指标，以填补目前的空白，特别是 对于患者认为至关重要的结果;（c）快速响应网络分析需求的波动。 (3)最先进的数据收集系统，包括（a）基于网络的临床电子数据采集， 具有快速错误解决方案、实时报告和数据监控工具的管理系统;（B） 使用移动的技术收集高质量患者报告结局数据的进展;以及 (c)自动报告，提供研究入组和进展的每日跟踪，以提高科学性 临床试验机构试验活动的质量和效率。 相关性（参见说明）： PFDN成立于2001年，旨在通过开展精心设计的 多中心观察性研究和临床试验，为诊断、预防和治疗提供信息。一 合格的，经验丰富的DCC是至关重要的，在帮助PFDN优化研究生产力通过有效的 研究设计、实施、数据收集、质量保证、监测和统计分析。RTI将 继续提供多学科专业知识，以支持高影响力的合作临床研究 并提供通信和后勤支持，以优化网络的效率和生产力。