NICHD Maternal-Fetal Medicine Units Networks

NICHD 母胎医学单位网络

• 批准号: 10379417
• 负责人: ALAN THEVENET N. TITA
• 金额: $ 29.7万
• 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 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10379417
• 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.

项目概要/摘要 阿拉巴马大学伯明翰分校 (UAB) 母胎医学 (MFM) 部门提交了这份报告 申请有限竞争更新以继续作为尤尼斯·肯尼迪临床中心参与 Shriver NICHD 母胎医学中心 (MFMU) 网络，以完成正在进行的试验。我们呈现 我们中心在 MFMU 网络中的属性和卓越表现记录，以及位于 路易斯安那州的奥克斯纳浸信会医疗中心。我们仍然致力于网络调查重大事件的目标 临床产科问题，特别是与低出生体重、早产、产科和医疗相关的问题 妊娠并发症。我们的女性生殖中心拥有著名的研究基础设施 Health (CWRH) 是该应用程序的核心，在成功领导大型企业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 在过去的六个 5 年周期中，UAB 始终发挥着领导作用，为 在指导委员会和分委员会层面进行网络试验，并进行了最高级别的网络试验 任何中心的效率，并大力参与所生成数据的呈现和发布。 在 MFMU 历史上的 32 个临床中心中，UAB 研究者拥有超过 17% 的网络论文第一作者 出版物和超过 17% 的全国会议演讲。我们调查小组的现任成员有 积累了超过300人年积极参与支持MFMU项目的经验；我们的研究 员工同样累计超过 300 名 MFMU 人年。 Alan Tita（医学博士、哲学博士）和 Brian Casey（医学博士）将继续 分别担任 PI 和候补 PI。调查团队包括 2 名前 MFMU PI 和 6 名 曾担任或现任网络协议主席或小组委员会成员的成员。 最后，根据患者招募、方案遵守、保留、随访、数据质量和研究启动- 根据正常运行时间，MFMU 网络数据协调中心历来将我们的中心列为第一名或第二名 2003 年至 2015 年间，参与中心占 71% (10/14)（总体排名第一，占 53% 的时间）。我们继续 成为最高效的网站：根据可用人口进行调整，我们招收了最多的参与者 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 符合筛选条件的患者成功加入网络研究的比例将使我们能够继续保持这一高水平 表现水平。如果这次有限的更新成功，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、强化 调查团队和经验丰富的人员全面实施和完成正在进行的 MFMU 网络协议和项目。这一成功延伸到了大型非 MFMU 财团的领导地位 临床试验和长期随访研究。在此，我们概述了优先考虑并充分参与的计划 正在进行的 MFMU 网络研究。