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: 9980201
• 负责人: MARIE G GANTZ
• 金额: $ 318.94万
• 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 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9980201
• 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; Documentation; Enrollment; Ensure; Equipment; Equipment and Supplies; Exhibits; Fecal Incontinence; Genetic; Genomics; Goals; Informatics; Infrastructure; Institution; Institutional Review Boards; Instruction; Leadership; Letters; Library Materials; Life; Logistics; Manuals; Manuscripts; Maps; 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; Performance; 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; biobank; clinical research site; cost effectiveness; data management; data quality; data sharing; design; electronic data; electronic data capture system; experience; flexibility; 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; sample collection; 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.

项目摘要（请参阅说明）： RTI建议继续作为NICHD骨盆底的数据协调中心（DCC） 疾病网络（PFDN），以支持改善骨盆底疾病女性的护理的使命 （PFD）通过进行精心设计的多中心观察研究和临床试验来为诊断提供信息 预防和治疗。我们将在当前PFDN周期中以DCC为基础，以提供 通过数据在研究设计和数据分析和运营支持方面具有统计领导力的网络 管理和后勤服务。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） 准备包括数据和安全监控委员会的安全报告； （4）合作 数据分析和研究结果的发布； （5）协调研究药物和安慰剂的制造， 获取研究设备和材料，以及生物标本的收集和运输； （6） 提供所有其他支持，包括管理临床站点的人力付款和后勤 会议和沟通的协调，以运行高效且富有成效的网络。 该应用具有特定的优势，可以提高PFDN的科学生产力： （1）DCC领导与Marie Gantz博士担任首席研究员（PI）和Dennis Wallace博士的连续性 作为替代PI监督PFD研究中经历的DCC团队，包括对骨盆器官的研究 脱垂，尿失禁和粪便失禁。 （2）来自RTI和北卡罗来纳大学教堂山的多学科专家，生物统计学， 统计遗传学，临床和生活结果质量，成本效益，计划评估和临床 PFD Care，他将与PFDN调查人员合作（a）开发创新的试验设计 基准对床位翻译研究； （b）制定新的结果措施以填补当前空白，特别是 对于结果，患者认为至关重要； （c）对网络分析需求的波动迅速响应。 （3）最新的数据收集系统，包括（a）基于网络的临床电子数据捕获和 具有快速误差解决以及实时报告和数据监视工具的管理系统； （b） 使用移动技术收集高质量患者报告的结果数据的进步；和 （c）自动报告，以每天跟踪研究入学率并进步以增强科学 临床现场试验活动的质量和效率。 相关性（请参阅说明）： PFDN成立于2001年，旨在通过进行精心设计的PFD妇女的护理 多中心观察研究和临床试验，以告知诊断，预防和治疗。一个 合格，经验丰富的DCC对于通过有效地帮助PFDN优化研究生产力至关重要 研究设计，实施，数据收集，质量保证，监视和统计分析。 RTI会 继续提供多学科专业知识，以支持高影响力的协作临床研究 并提供通信和后勤支持，以优化网络的效率和生产力。