UNIVERSITY OF SOUTHERN CALIFORNIA CLINICAL TRIALS UNIT

南加州大学临床试验单位

• 批准号: 7561672
• 负责人: FRED R SATTLER
• 金额: $ 192.47万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7561672
• 关键词: AIDS clinical trial group; Adolescent; Area; California; Cardiology; Child Care; Clinic; Clinical; Clinical Trials Unit; Clinical Virology; Developed Countries; Developing Countries; Development; Documentation; Drug Kinetics; Endocrinology; Endpoint Determination; Enrollment; Evaluation; Faculty; Future; Goals; HIV; Hepatology; Hispanics; Human Resources; Immunology; Laboratories; Latino; Learning; Mentors; Minority; Monitor; Patient Care; Patients; Performance; Pharmacodynamics; Pharmacogenomics; Prevention strategy; Principal Investigator; Protocols documentation; Recruitment Activity; Relative (related person); Research; Research Personnel; Resources; Shapes; Shipping; Ships; Site; Source; Study Subject; Testing; The science of Mycology; Time; Translational Research; Tuberculosis; Universities; Weight; Woman; Women' s Health; career; cost; expectation; instructor; meetings; men; novel

DESCRIPTION (provided by applicant): The Clinical Trials Unit (CTU) at DSC was the number one performing Unit for relative cost per weighted accrual for the past 5 years, number two for % enrollment of minorities for the past three years and number two for overall accrual during the past 12 months (through 6/05). There are currently 103 study subjects on ACTG studies at USC. There are 63% Latinos and 27% women of the nearly 3000 patients attending the Rand Schrader Clinic, site of the USC CTU and CRS, which closely replicates our accrual to aACTG studies. The Site Evaluation Subcommittee (9/2004) highly commended the Unit on its exceptional performance for relative cost per weighted accrual, monitoring-source documentation, monitoring-endpoint determination, enrollment of Hispanics, laboratory shipping score, and timeliness of protocol registrations packets. As Dr. Sattler took over as Principal Investigator on 7/1/05, the CTU was reorganized. Several former ACTG, now mid-career investigators were recruited as Key Personnel, and several nationally renowned USC investigators with expertise in areas of high priority for Network research were included as Consultants and Collaborators. The primary goal of these changes was to augment the scientific contributions from the USC CTU with the expectation that the breadth and expertise of these investigators will provide a major impact in helping to shape the future CTN research agenda. This group of distinguished investigators includes 8 women and 5 faculty representing ethnic or racial minorities with expertise in clinical virology; immunology; mycology; tuberculosis; endocrinology/metabolism; hepatology; cardiology; adolescent and child care, women's health; and pharmacokinetics, pharmacodynamics and pharmacogenomics. Moreover, the USC CTU will continue its long-time commitment to the development of junior investigators, as Key Personnel will mentor 4 junior faculty or fellow-instructor trainees (2 women and 2 minority men) as CRS investigators in learning the principles of HIV clinical and translational research. Finally, this investigative group will allow the USC CTU/CRS to continue to perform at the same high level as in recent years in achieving the Network research agenda. They will also participate in ACTG group-wide meetings and contribute concept proposals for novel new treatment and prevention strategies to be tested in resource limited settings (e.g. East LA) that will often be applicable for the care of patients in developing countries. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）： DSC的临床试验单元（CTU）是过去5年中每次加权应计的相对成本的第一表现单元，在过去三年中，少数族裔的少数族裔百分比为第二，在过去的12个月中（至6/05）的总计计算二号。目前，在USC有103个有关ACTG研究的研究科目。在USC CTU和CRS的兰德·施拉德诊所（Rand Schrader Clinic）的近3000名患者中，有63％的拉丁裔和27％的妇女，这些患者与AACTG研究密切复制了我们的应计。现场评估小组委员会（9/2004）高度赞扬该部门的出色表现，每次加权应计，监视源文档，监视 - 端点确定，西班牙裔的入学率，实验室运输评分以及协议注册数据包的及时性。当Sattler博士于05年7月1日接任首席研究员时，CTU进行了重组。几名以前的ACTG，现在是职业中期的调查人员被招募为关键人员，其中几位全国知名的USC调查人员在高优先级的网络研究领域具有专业知识，被包括为顾问和合作者。这些变化的主要目标是增加USC CTU的科学贡献，并期望这些研究人员的广度和专业知识将在帮助塑造未来的CTN研究议程方面产生重大影响。这组杰出的研究人员包括8名妇女和5位代表具有临床病毒学专业知识的种族或种族少数民族的教师；免疫学；真菌学结核;内分泌学/代谢；肝病学；心脏病学；青少年和育儿，妇女健康；以及药代动力学，药效学和药物基因组学。此外，USC CTU将继续对初级调查人员的发展进行长期承诺，因为关键人员将指导4个初级教师或其他教师学员（2名女性和2名少数男性），因为CRS研究人员在学习HIV临床和翻译研究原理方面。最后，这个调查小组将允许USC CTU/CRS继续与近年来达到网络研究议程相同的高水平。他们还将参加ACTG小组范围内的会议，并为在资源有限的环境（例如East La）中进行测试的新型新待遇和预防策略做出概念建议，这些建议通常适用于发展中国家患者的护理。 管理组件：