Northwestern University Clinical Trial Unit

描述（由申请人提供）： 西北大学临床试验单位（NU-CTU）是艾滋病临床试验组内现有的一个非常富有成效的临床单位。NU-CTU已被邀请参加目前ACTG的网络申请，该网络将专注于转化研究/药物开发，优化临床管理，包括合并症，疫苗研究和开发，预防母婴传播和预防艾滋病毒感染。NU-CTU由5个独立的临床研究中心（CRS）组成，在西北大学的行政保护伞下运作。这5个地点是：西北大学临床研究中心（NU-CRS）、拉什大学临床研究中心（R J-CRS）和CORE中心临床研究中心（CC-CRS）均位于芝加哥，位于塞内加尔达喀尔的Fann医院/Universite Chelsea Anta Diop的国际研究中心（SN-CRS），以及位于达拉斯的Peabody健康中心（黑人临床研究联盟成员）（PC-CRS）。ACTG领导层已邀请现有的3个ACTG研究中心（NU-CRS、RU-CRS和CC-CRS）参与此次再竞争网络资助。PC-CRS不是一个现有的研究中心，但它已收到ACTG领导层的特别邀请，以加强少数患者的参与和少数研究者的发展。SN-CRS没有被正式邀请，因为只有现有的ACTG国际研究中心有资格，但该研究中心是NIAID/CIPRA赠款获得者和Fogarty赠款获得者，完全有能力按照NIH标准进行临床试验。我们现在纳入这些研究中心是因为它们能够像现有的国际研究中心一样进行临床试验，它们将是唯一位于西非的研究中心，唯一主要感染HIV-1亚型A/G的患者的研究中心，也是唯一少数患者感染或合并感染HIV-2的研究中心。我们相信这些独特的功能将大大提高ACTG的科学议程。NU-CTU是一个高效的团队，在进行多中心，转化研究和治疗性临床试验方面已经建立了良好的记录，在过去5年的评估期内，患者人数排名第一，科学生产力排名第三。我们期望无缝过渡到本申请中描述的新结构。 行政部门：

DESCRIPTION (provided by applicant): The Northwestern University Clinical Trials Unit (NU-CTU) is an existing and very productive clinical unit within the AIDS Clinical Trails Group. The NU-CTU has been invited to participate in the current ACTG application for a Network which will focus on translational research/drug development, optimization of clinical management including co-morbidities, vaccine research and development, prevention of mother-to-child transmission and prevention of HIV infection. The NU-CTU consists of 5 individual clinical research sites (CRS) operating under the Northwestern University administrative umbrella. The 5 sites are: Northwestern University Clinical Research Site (NU-CRS), Rush University Clinical Research Site (R J-CRS), and the CORE Center Clinical Research Site (CC-CRS) all located in Chicago, an international site at Fann Hospital/Universite Cheikh Anta Diop in Dakar, Senegal (SN-CRS), and the Peabody Health Center, a member of the Black Clinical Research Consortium, located in Dallas (PC-CRS). The ACTG Leadership has invited the 3 existing ACTG sites, NU-CRS, RU-CRS, and CC-CRS to participate in this recompetitive network grant. The PC-CRS is not an existing site but it has received a special invitation to participate from the ACTG Leadership for the purpose of enhancing minority patient involvement and minority research investigator development. The SN-CRS was not formally invited as only existing ACTG international sites were eligible, however this site is an NIAID/CIPRA grant awardee and a Fogarty grantee and is fully capable of performing clinical trials to NIH standards. We include them now because they are as capable of performing clinical trials as the existing international sites, they would be the only site located in West Africa, the only site with patients predominantly infected with HIV-1 subtype A/G, and the only site with a significant minority of patients infected or co-infected with HIV-2.. We believe these unique features would greatly enhance the ACTG scientific agenda. The NU-CTU is a highly productive and efficient group with an already established track record in performing multicenter, translational research and therapeutic clinical trials, ranking #1 in patient accrual and #3 in scientific productivity for the last 5 year evaluation period. We expect a seamless transition to the new structure described in this application. ADMINISTRATIVE COMPONENT: