Brown/WIH Eunice Kennedy Shriver NICHD MFM Units Network Site

描述(由申请人提供)：布朗大学/罗德岛妇婴医院(WIH)的母胎医学部坚定地致力于继续高水平地参与NICHD MFMU网络，以调查产科临床问题，特别是与低出生体重、早产和怀孕相关的问题。我们在这些领域进行临床试验方面拥有丰富的经验，拥有强大、稳定和成熟的研究基础设施。怀俄明州妇产科医院每年出生9000名新生儿，是全国最大的产科单位之一。在过去两个五年的MFMU网络周期中，我们一直是参与中心。Dwight J.Rouse，医学博士，MSPH于2009年9月被招募为Brown/WIH网络首席调查员。在此之前，他是2001年至2009年阿拉巴马大学伯明翰分校(UAB)MFMU网络站点的首席调查员。在担任该职位期间，他保持了UAB作为重要和领先的网络中心的地位(一直位居前三名)。根据该网络的生物统计协调中心(BCC)发布的最新累积绩效报告，Brown/WIH在14个中心中的数据质量(编辑和审计)排名第二，在患者招募和留住方面排名第七。我们有信心能够保持我们在前者的高排名，并在后者中提高我们的排名。Rouse博士的教师招聘方案包括额外的部门学术不限成员名额资助，相当于两名专门为该网络服务的研究护士的全职工作。有了这笔资金，我们聘请了三名研究助理(而不是两名护士)，并重新配置了我们的人员部署。因此，我们的招聘人数大幅增加。事实上，自2009年9月以来，Brown/WIH筛选了最多的患者，并招募了第二多的患者参加自那时以来正在进行的唯一随机网络试验-SCAN试验(17-羟孕酮己酸酯用于预防短子宫颈未足月的早产)我们还大幅增加了TSH试验的筛查，在一个月内最多筛查205名(个人同意的)患者。我们相信，作为NICHD MFMU网络中心，我们将在未来五年保持良好的竞争地位。我们的目标不仅是参与MFMU网络，而且要使Brown/WIH在协议开发、启动和完成、数据解释、手稿准备和在顶级期刊上发表以及支持所有协议和中心的网络功能方面成为其领先网站之一。

DESCRIPTION (provided by applicant): The Division of Maternal-Fetal Medicine at Brown University/Women and Infants Hospital of Rhode Island (WIH) has a strong commitment to a continued high-level of participation in the NICHD MFMU Network for the purpose of investigating problems in clinical obstetrics, particularly those related to low birth weight, prematurity, and medical problems of pregnancy. We have extensive experience in performing clinical trials in these areas, and a strong, stable, and proven research infrastructure. WIH, with 9,000 annual births, is one of the largest obstetric units in the country. We have been a participating center for the past two 5-year cycles of the MFMU Network. Dwight J. Rouse, MD, MSPH was recruited to be the Brown/WIH Network Principal Investigator in September, 2009. Prior to this he was the Principal Investigator for the University of Alabama at Birmingham (UAB) MFMU Network site from 2001 to 2009. In that role, he maintained UAB as a vital and leading Network center (consistently ranked in the top three). According to the most recent cumulative performance report issued by the Network's Biostatistical Coordinating Center (BCC) Brown/WIH was ranked 2nd highest in Data Quality (edits and audits) and 7th in Patient Recruitment and Retention among 14 centers. We are confident we can retain our high ranking in the former and improve our ranking in the latter. Dr. Rouse's faculty recruitment package included additional Departmental academic open-ended funding for the full time equivalent of two research nurses who are dedicated solely to the Network. With this funding we hired three research assistants (rather than two nurses) and re-configured the deployment of our personnel. Accordingly, our recruitment has increased dramatically. Indeed, since 9/09, Brown/WIH has screened the greatest number of patients, and recruited the second greatest number to the only randomized Network trial ongoing since that time-the SCAN Trial (17-a hydroxyprogesterone caproate for the prevention of preterm birth in nulliparas with a short cervix) We also dramatically increased screening for the TSH trial, to a maximum of 205 (individually-consented) patients in one month. We believe that we remain well positioned for competitive renewal as an NICHD MFMU Network center for the next five years. Our goal is not only to participate in the MFMU Network, but to turn Brown/WIH into one of its leading sites in terms of protocol development, start-up and completion, data interpretation, manuscript preparation and publication in top-tier journals, and support of Network functions across all protocols and centers.