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

NICHD 母胎医学单位 (MFMU) 网络：临床中心

基本信息

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
项目类别：
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&apos 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

项目摘要

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.

抽象的宾夕法尼亚大学妇产科体现了悠久的传统卓越的临床和转化研究在此应用程序中提供了有关产科的信息。在宾夕法尼亚大学两家医院进行临床试验的服务和良好的记录（宾夕法尼亚州）医疗系统 – 宾夕法尼亚大学医院 (HUP) 和宾夕法尼亚医院 (PAH) 每年约有 9,500 名患者在宾夕法尼亚大学分娩，其中许多患者患有高宾夕法尼亚大学的产科人群具有不同的种族和民族背景，这是一个参加母胎医学单位 (MFMU) 网络研究的重要资产。位于宾夕法尼亚大学的 MFMU 网络站点包括：1) 一位经验丰富的护士协调员，负责监督所有临床研究；2) 第二名注册护士对于完成复杂的网络研究（例如 PACT、PASC- PREG); 3) 一名生物样本技术人员，负责编写操作手册并监督采集，生物样本的处理和数据库；4) 在所有主要临床中心成功招募门诊患者在 HUP 和 PAH；5) 能够扩展到提供分娩和分娩保障的 24/7 模式 HUP 和 PAH 的单位；6) 每个 MFMU 网络研究的数据提取手册，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 网络团队包括新员工的招聘、入职、监管事务以及所有研究中的良好临床实践 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。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，每个研究者都有一个令人兴奋的研究议程，为研究增添了独特的视角 MFMU 网络。研究人员提出了该应用程序的三个具体目标：1) 开发和实施 MFMU 网络协议，包括招募、研究干预和后续行动 2) 为 MFMU 网络研究提供最高质量的数据，并在及时；3) 与其他 MFMU 网络中心合作，确定潜在领域研究并分析和发布 MFMU 网络调查团队进行的研究。宾夕法尼亚大学建立了一个非常成功的 MFMU 网络临床站点，该站点将支持 NICHD 的指导原则塑造 21 世纪多中心临床研究的格局，包括增强选择的 ligor 研究、网络基础设施对更广泛的研究人员的可用性、数据共享和访问生物样本，以及将不同人群纳入网络研究。