NICHD Maternal-Fetal Medicine Units (MFMU) Network: Clinical Center

NICHD 母胎医学单位 (MFMU) 网络：临床中心

• 批准号: 10680961
• 负责人: SAMUEL I. PARRY
• 金额: $ 35.75万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2030-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10680961
• 关键词: Ancillary Study; Area; Biological Specimen Banks; Caring; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Collection; Computerized Medical Record; Conduct Clinical Trials; Data; Development; Discipline of obstetrics; Disparity; Enrollment; Ensure; Environment; Equity; Ethnic Origin; Faculty; Fetus; Functional disorder; Funding; Genetic; Genomics; Goals; Good Clinical Practice; Gynecology; Health system; Heart; High-Risk Pregnancy; Hospitals; Hypertension; Intervention Studies; Leadership; Longterm Follow-up; Manuals; Maternal and Child Health; Maternal-Fetal Medicine Units Network; Maternal-fetal medicine; Medical Records; Modeling; Multicenter Neonatal Research Network; Multicenter Studies; Multicenter Trials; National Institute of Child Health and Human Development; Neonatal; Network Infrastructure; Nurses; Observational Study; Operations Research; Outpatients; Patients; Pediatric Hospitals; Pennsylvania; Performance; Persons; Phase; Philadelphia; Population; Population Heterogeneity; Positioning Attribute; Post-Acute Sequelae of SARS-CoV-2 Infection; Postpartum Hypertension; Postpartum Women; Pregnant Women; Premature Birth; Proteomics; Protocols documentation; Publications; Publishing; Registered nurse; Regulatory Affairs; Research; Research Infrastructure; Research Personnel; Second Labor Stage; Shapes; Site; Text; Translational Research; United States Dept. of Health and Human Services; United States National Institutes of Health; Universities; University Hospitals; Women' s Health; Work; Writing; clinical center; clinical research site; cohort; data access; data repository; data sharing; disparity reduction; experience; follow-up; high risk; improved; improved outcome; innovation; maternal outcome; neonatal outcome; obstetric services; operation; participant enrollment; patient population; pregnant; premature; programs; racial diversity; randomized trial; randomized, clinical trials; recruit; reproductive; shared database; support network

Abstract The University of Pennsylvania's Department of Obstetrics and Gynecology reflects a long tradition of excellence in clinical and translational research. In this application, information is provided on the obstetrical service and proven track record for conducting clinical trials at two hospitals in the University of Pennsylvania (Penn) Health System – the Hospital of the University of Pennsylvania (HUP) and Pennsylvania Hospital (PAH). Each year, approximately 9,500 patients are delivered at Penn, and many of these patients have high- risk pregnancies. The obstetric population at Penn has a diverse racial and ethnic background, which is an important asset for enrollment in Maternal-Fetal Medicine Units (MFMU) Network studies. Key assets of the MFMU Network site at Penn are: 1) an experienced Nurse Coordinator who oversees all the clinical studies; 2) a second registered nurse who is critical for completion of complicated Network studies (e.g., PACT, PASC- PREG); 3) a biospecimens technician who has written manuals of operation and oversees collection, processing, and data banking for biospecimens; 4) successful outpatient recruitment at all major clinical sites at HUP and PAH; 5) the ability to expand to a 24/7 model that provides coverage on the labor and delivery units at HUP and PAH; 6) data abstraction manuals for each MFMU Network study that ensure accurate ascertainment of clinical data from the electronic medical record; and 7) support by the MFM Research Program and the Women's Health Clinical Research Center at Penn, which assist the MFMU Network team with recruitment of new staff, onboarding, regulatory affairs, and good clinical practices in all research operations. The MFMU Network research team works closely with the Neonatal Research Network clinical center at the Children's Hospital of Philadelphia to provide neonatal follow-up for MFMU Network studies. The investigative team for the MFMU Network clinical center at Penn has substantial experience directing multicenter studies, and each investigator has an exciting research agenda that adds unique perspectives to the MFMU Network. The investigators propose three specific aims for this application: 1) Develop and implement MFMU Network protocols, including recruitment, study interventions, and follow-up examinations; 2) Provide the highest quality data for MFMU Network studies and provide these data in a timely fashion; and 3) Collaborate with the other MFMU Network centers to identify areas for potential research and to analyze and publish studies performed by the MFMU Network. The investigative team at Penn has built a highly successful MFMU Network clinical site that will support the NICHD's guiding principles shaping the 21st century landscape for multi-site clinical research, including enhanced rigor for selecting studies, availability of Network infrastructure to a wider range of investigators, data sharing and access to biospecimens, and inclusion of diverse populations in Network studies.

摘要 宾夕法尼亚大学的妇产科反映了一个悠久的传统 在临床和翻译研究方面表现出色。在本申请中，提供了关于产科的信息 在宾夕法尼亚大学两家医院进行临床试验的服务和经过证明的跟踪记录 (宾夕法尼亚)卫生系统-宾夕法尼亚大学医院(HUP)和宾夕法尼亚医院 (PAH)。每年，宾夕法尼亚大学大约有9500名患者接生，其中许多患者患有高- 怀孕的风险。宾夕法尼亚大学的产科人口有不同的种族和民族背景，这是一个 参加母婴医学部(MFMU)网络研究的重要资产。公司的主要资产 宾夕法尼亚大学的MFMU网络站点有：1)一名经验丰富的护士协调员，负责监督所有临床研究；2) 对完成复杂网络研究至关重要的第二名注册护士(例如，PACT、PASC- PRIG)；3)编写操作手册并监督收集的生物检验技术员， 生物标本的处理和数据库；4)在所有主要临床地点成功招募门诊病人 在HUP和PAH；5)能够扩展到全天候模式，提供对分娩和分娩的覆盖 HUP和PAH的单位；6)每个MFMU网络研究的数据摘要手册，确保准确 从电子病历中确定临床数据；以及7)MFM Research的支持 项目和宾夕法尼亚大学妇女健康临床研究中心，协助MFMU网络团队 在所有研究中招募新员工、入职、监管事务和良好的临床实践 行动。MFMU网络研究团队与新生儿研究网络临床密切合作 费城儿童医院中心为MFMU网络研究提供新生儿随访。这个 宾夕法尼亚大学MFMU网络临床中心的调查团队拥有丰富的指导经验 多中心研究，每个研究人员都有令人兴奋的研究议程，为 MFMU网络。研究人员为这一应用程序提出了三个具体目标：1)开发和 实施MFMU网络协议，包括招募、研究干预和后续行动 检查；2)为MFMU网络研究提供最高质量的数据，并在 及时；以及3)与其他MFMU网络中心合作，确定潜在的领域 研究并分析和发表由MFMU网络进行的研究。调查小组在 宾夕法尼亚大学已经建立了一个非常成功的MFMU网络临床网站，将支持NICHD的指导原则 塑造21世纪多地点临床研究的格局，包括提高选择的严谨性 研究、向更广泛的调查人员提供网络基础设施、数据共享和访问 生物群落，以及在网络研究中纳入不同的种群。