NICHD Maternal-Fetal Medicine Units Networks

NICHD 母胎医学单位网络

• 批准号: 10253395
• 负责人: ALAN THEVENET N. TITA
• 金额: $ 26.21万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10253395
• 关键词: Address; Adherence; Affect; Alabama; Authorship; Baptist Church; COVID-19 pandemic; Chairperson; Chronic; Clinical; Clinical Research; Clinical Trials; Conduct Clinical Trials; Data; Data Coordinating Center; Data Management Resources; Discipline of obstetrics; Doctor of Philosophy; Enrollment; Environment; Evaluation; Faculty; Fetal Growth; Follow-Up Studies; Goals; Home; Human Resources; Hypertension; Individual; Infant; Lead; Leadership; Longterm Follow-up; Louisiana; Low Birth Weight Infant; Maternal complication; Maternal-Fetal Medicine Units Network; Maternal-fetal medicine; Medical; Medical center; National Institute of Child Health and Human Development; Observational Study; Participant; Patient Recruitments; Patients; Performance; Perinatal; Persons; Play; Population; Postpartum Hemorrhage; Pre-Eclampsia; Pregnancy; Pregnancy Complications; Pregnant Women; Premature Birth; Prenatal care; Prevention; Protocols documentation; Public Health; Publications; Recording of previous events; Reproductive Health; Research; Research Activity; Research Design; Research Infrastructure; Research Personnel; Resources; Role; Site; System; Time; Training; U-Series Cooperative Agreements; Universities; Woman; clinical center; cost effective; data centers; data quality; design; evidence base; experience; fetal; follow-up; high risk population; infant morbidity; medical complication; meetings; member; next generation; obstetrical complication; participant retention; premature; prevent; programs; randomized trial; recruit; secondary analysis; substance use; success

PROJECT SUMMARY/ABSTRACT The Maternal-Fetal Medicine (MFM) Division of the University of Alabama at Birmingham (UAB) submits this application for limited competition renewal to continue to participate as a clinical center of the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) Network in order to complete ongoing trials. We present our center’s attributes and record of exceptional performance within the MFMU Network, as well as a subsite at Ochsner Baptist Medical Center in Louisiana. We remain committed to the Network’s goals of investigating major problems in clinical obstetrics, particularly those related to low birth weight, prematurity, obstetric and medical complications of pregnancy. The renowned research infrastructure within our Center for Women’s Reproductive Health (CWRH) is a centerpiece of this application and has extensive experience in successfully leading large clinical trials and observational studies both within and outside the MFMU Network. As a Network center over the last six 5-year cycles, UAB has consistently played a leadership role in providing research direction for the Network at the Steering Committee and sub-committee levels, conducted Network trials with the highest efficiency of any center, and participated significantly in the presentation and publication of data generated. Among 32 clinical centers in the history of the MFMU, a UAB investigator has first-authored >17% of Network publications and >17% of presentations at national meetings. Current members of our investigative team have accumulated over 300 person-years’ experience of active participation in support of MFMU projects; our research staff similarly cumulate over 300 MFMU person-years. Alan Tita, MD, PhD and Brian Casey, MD will continue to serve as PI and Alternate PI, respectively. The investigative team includes 2 previous MFMU PI’s and 6 members who have served or currently serve as Network protocol chairpersons or Subcommittee members. Finally, on the basis of patient recruitment, protocol adherence, retention, follow-up, data quality, and study start- up time, the MFMU Network Data Coordinating Center historically ranked our center #1 or #2 among the participating centers 71% (10/14) of the time between 2003 and 2015 (#1 overall, 53% of the time). We continue to be the most efficient site: adjusted for the available population, we enroll the highest number of participants in most network studies. Our enriched high-risk population, strong research culture and 24/7 coverage and the high proportion of screen-eligible patients successfully enrolled into network studies will allow us to continue this high level of performance. If successful in this limited renewal, we will continue to deploy our facilities, data management systems (including our electronic perinatal record system), recruitment resources, reinforced investigative team and highly experienced personnel toward fully implementing and completing ongoing MFMU Network protocols and projects. This success extends to leadership of large non-MFMU consortia conducting clinical trials and long term follow-up studies. Herein, we outline our plans to prioritize and fully participate in ongoing MFMU Network studies.

项目摘要/摘要 伯明翰大学（UAB）的阿拉巴马大学母亲医学（MFM） 申请有限竞争申请继续作为Eunice Kennedy的临床中心继续参与 Shriver NICHD产妇医学单位（MFMU）网络，以完成正在进行的试验。我们在场 我们中心在MFMU网络中的属性和出色性能的记录，以及 路易斯安那州的Ochsner Baptist医疗中心。我们仍然致力于该网络调查专业的目标 临床产科问题，特别是与低出生体重，早产，产科和医学有关的问题 怀孕并发症。我们妇女生殖中心内的著名研究基础设施 健康（CWRH）是此应用程序的核心，在成功领导大型方面拥有丰富的经验 MFMU网络内外的临床试验和观察性研究。作为网络中心 最近六个5年的周期，UAB一直在为研究方向提供研究方向 指导委员会和小组委员会级别的网络进行了最高的网络试验 任何中心的效率，并大量参与生成的数据的介绍和发布。 在MFMU历史上的32个临床中心中，UAB调查员首先拥有> 17％的网络 在国家会议上的出版物和> 17％的演讲。我们调查团队的现任成员有 积累了300多人年度积极参与MFMU项目的经验；我们的研究 员工类似地累积了超过300 MFMU的人年。医学博士Alan Tita和医学博士Brian Casey将继续 分别用作PI和备用PI。调查团队包括2个以前的MFMU PI和6个 曾担任或目前担任网络协议主席或小组委员会成员的成员。 最后，基于患者招聘，方案依从性，保留，随访，数据质量和研究开始 - UP时间，MFMU网络数据协调中心历史上将我们的中心排名第一或＃2在 参与中心在2003年至2015年之间的时间为71％（10/14）（总＃1，53％的时间）。我们继续 成为最有效的网站：针对可用人群进行调整，我们招募了最多的参与者 大多数网络研究。我们丰富的高风险人群，强大的研究文化和24/7覆盖范围以及高 在网络研究中成功入学的符合屏幕资格的患者比例将使我们能够继续如此高 性能水平。如果在此有限的续约中成功，我们将继续部署我们的设施，数据 管理系统（包括我们的电子围产期记录系统），招聘资源，加强 调查团队和经验丰富的人员，以完全实施和完成正在进行的MFMU 网络协议和项目。这一成功扩展到了大型非MFMU财团进行的领导 临床试验和长期随访研究。在此，我们概述了优先级和全面参与的计划 正在进行的MFMU网络研究。