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)是艾滋病临床试验小组中现有的一个非常有成效的临床单位。NU-CTU已被邀请参加目前ACTG的网络申请，该网络将侧重于转译研究/药物开发、包括共病在内的临床管理的优化、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个独立的临床研究站点(CRS)组成，这些站点在西北大学的行政管理下运营。这5个网站是：西北大学临床研究网站(NU-CRS)，拉什大学临床研究网站(R J-CRS)，以及核心中心临床研究网站(CC-CRS)，都位于芝加哥，位于塞内加尔达喀尔的范恩医院/大学Cheikh Anta Diop的国际网站(SN-CRS)，以及位于达拉斯的黑人临床研究联盟成员皮博迪健康中心(PC-CRS)。ACTG领导层已邀请ACTG现有的3个站点NU-CRS、RU-CRS和CC-CRS参与这一重新竞争的网络赠款。PC-CRS不是一个现有的网站，但它收到了ACTG领导层的特别邀请，参加的目的是加强少数族裔患者的参与和少数族裔研究调查员的发展。SN-CRS没有被正式邀请，因为只有现有的ACTG国际站点有资格，但该站点是NIAID/CIPRA获奖者和Fogarty获奖者，完全有能力按照NIH标准进行临床试验。我们现在纳入它们是因为它们与现有的国际站点一样有能力进行临床试验，它们将是西非唯一的站点，唯一感染HIV-1 A/G亚型患者的站点，以及唯一感染或合并感染HIV-2的少数患者的站点。我们相信，这些独特的特点将极大地加强ACTG的科学议程。NU-CTU是一个高生产力和高效率的团队，在执行多中心、转化性研究和治疗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，在患者收益方面排名第一，在科学生产率方面排名第三。我们希望能够无缝过渡到本申请中描述的新结构。 管理组件：

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: