UNIVERSITY OF SOUTHERN CALIFORNIA CLINICAL TRIALS UNIT

南加州大学临床试验单位

• 批准号: 7450883
• 负责人: FRED R SATTLER
• 金额: $ 203.14万
• 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/7450883
• 关键词: AIDS clinical trial group; Adolescent; Area; California; Cardiology; Category Rating Scale; Child Care; Clinic; Clinical; Clinical Trials; 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; Numbers; Patient Care; Patients; Performance; Pharmacodynamics; Pharmacogenomics; Prevention strategy; Principal Investigator; Protocols documentation; Recruitment Activity; Relative (related person); Research; Research Personnel; Resources; Score; Shapes; Shipping; Ships; Site; Source; Study Subject; Testing; The science of Mycology; Time; Translational Research; Tuberculosis; Universities; Weight; Woman; Women' s Health; career; concept; cost; expectation; instructor; 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的临床试验部门（CTU）在过去5年中是加权累积相对成本的第一执行单位，在过去3年中是少数族裔入组百分比的第二执行单位，在过去12个月（截至2005年6月）中是总累积的第二执行单位。目前有103名研究对象在南加州大学进行ACTG研究。在兰德施拉德诊所（南加州大学CTU和CRS的所在地）就诊的近3000名患者中，63%为拉丁裔，27%为女性，这与我们对aACTG研究的研究结果非常相似。研究中心评价小组委员会（9/2004）高度赞扬了该股在加权应计相对成本、监测源文件、监测终点确定、西班牙裔美国人入组、实验室运输评分和方案登记包及时性方面的出色表现。随着Sattler博士于2005年7月1日接任首席调查员，CTU进行了重组。几位前ACTG，现在职业生涯中期的调查人员被招募为关键人员，几位在网络研究的高优先级领域具有专业知识的全国知名的南加州大学调查人员被列为顾问和合作者。这些变化的主要目标是增加南加州大学CTU的科学贡献，期望这些研究人员的广度和专业知识将在帮助塑造未来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名教师，他们代表少数民族或种族，具有临床病毒学、免疫学、真菌学、结核病、内分泌学/代谢学、肝病学、心脏病学、青少年和儿童保健、妇女健康以及药代动力学、药效学和药物基因组学方面的专业知识。此外，南加州大学CTU将继续长期致力于初级研究人员的发展，因为关键人员将指导4名初级教师或研究员培训生（2名女性和2名少数民族男性）作为CRS研究人员学习艾滋病毒临床和转化研究的原则。最后，这个调查小组将使南加州大学CTU/CRS在实现网络研究议程方面继续保持与近年来相同的高水平。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（例如洛杉矶东部）中进行测试的新型治疗和预防策略提供概念提案，这些策略通常适用于发展中国家的患者护理。 行政部门：