Clinical Trials Network: The Texas Node

临床试验网络：德克萨斯节点

• 批准号: 8324244
• 负责人: MADHUKAR H. TRIVEDI
• 金额: $ 77.04万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8324244
• 关键词: Address; Admission activity; Adolescent; Adopted; Adoption; Adult; African American; Alcohol or Other Drugs use; Algorithms; Area; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Network; Commit; Communities; Complement; Development; Disease; Effectiveness; Faculty; Female; Female Adolescents; Funding; Funding Mechanisms; Future; Grant; HIV; Health Personnel; Hispanics; Inpatients; Intervention; Joints; K-Series Research Career Programs; Latino; Lead; Medical; Medical center; Mental disorders; Minority; Monitor; Multi-Institutional Clinical Trial; National Institute of Drug Abuse; Outpatients; Patients; Performance; Pharmaceutical Preparations; Pharmacological Treatment; Policies; Population; Population Study; Procedures; Production; Protocols documentation; Publications; Research; Research Personnel; Resources; Site; Structure; Substance Use Disorder; System; Texas; Training; Universities; Voice; Work; addiction; austin; career development; chronic pain; data management; design; effectiveness clinical trial; effectiveness trial; experience; innovation; medical specialties; metropolitan; next generation; novel strategies; organizational structure; outreach program; pre-clinical; preclinical study; treatment program

DESCRIPTION (provided by applicant): This application proposes a new Clinical Trials Network (CTN) node representing North Texas. The North Texas Node (NTN) is comprised of the University of Texas Southwestern Medical Center in Dallas (UT Southwestern) and seven Community Treatment Providers (CTPs) in Dallas, Ft. Worth, Austin, and El Paso. UT Southwestern brings together a faculty with extensive experience in the preclinical and clinical study of substance use disorders, the design, implementation, and analysis of multi-site, efficacy-effectiveness clinical trials in both adolescents and adults the pharmacological treatment of comorbid disorders, and cultural issues in addiction. UT Southwestern faculty will collaborate with CTPs representing over 11,000 annual inpatient and outpatient admissions for a primary substance use disorder, with large populations of Hispanic/Latino, African-American, adolescent, and female patients. The CTPs and associated sites also offer specialized treatment and outreach programs for HIV+ patients. The NTN utilizes an administrative and organizational structure that carefully considers the CTN structure, its policies and procedures, and the initiation of centralized clinical, data management/statistical, and logistical centers. The Node's organization also provides a strong voice to our CTPs, assuring their presence on all committees, teams, and workgroups. For example, the NTN has initiated mechanisms to develop new protocols that involve a joint CTP-UT Southwestern effort, as evidenced by our Concept Proposal that addresses an unmet clinical need identified by the Node's CTPs. This collaborative structure will enable the NTN to take the lead in the development of future of protocols within the CTN, in addition to ancillary and externally funded studies that maximize the CTN platform. This system also incorporates UT Southwestern's preclinical T32 and clinical R25 NIDA training grants to encourage resident, fellow, and faculty career development within the CTN, including K awards. Protocol implementation will be assured by our exceptionally skilled management team and trainers from UT Southwestern's previous and ongoing multi-site clinical trials and a cadre of CTP sites with significant collaborative research experience. The effectiveness of the NTN in developing, implementing and disseminating the results of clinical trials will be assisted by the NTN's own Performance Assessment System, which will complement the CTN's performance monitors. Our Concept Proposal, which proposes a study of the effects of medication algorithms to treat adolescents with substance use and comorbid disorders, reveals our Node's ability to design state-of-the-art effectiveness trials that maximize the potential of the CTN framework. We believe the structure and organization of the NTN, as well as its committed and highly experienced investigators, complements and extends the work of the CTN.

描述（由申请人提供）： 该申请提出了一个代表北德克萨斯州的新临床试验网络（CTN）节点。北德克萨斯节点（NTN）由达拉斯（UT西南部）的德克萨斯大学西南医学中心和英尺达拉斯的七个社区治疗提供者（CTPS）组成。值得，奥斯丁和埃尔帕索。 UT Southwestern在临床前和临床研究中汇集了一项丰富经验的教师，对青少年和成人的多站点，效能效应临床试验的设计，实施和分析对合并症疾病的药物治疗以及成瘾问题的文化问题。 UT西南教师将与CTP合作，代表了一年的初级药物使用障碍的年度住院和门诊入院，其中大量西班牙裔/拉丁裔，非裔美国人，青少年和女性患者。 CTP和相关站点还为HIV+患者提供专门的治疗和外展计划。 NTN采用了一种行政和组织结构，该结构仔细考虑了CTN结构，其政策和程序以及集中式临床，数据管理/统计和后勤中心的启动。节点的组织还为我们的CTP提供了强烈的声音，确保他们在所有委员会，团队和工作组中的存在。例如，NTN启动了开发涉及西南努力的新方案的机制，这是我们概念提案所证明的，该概念提案解决了节点CTPS确定的未满足的临床需求。除了最大化CTN平台的辅助和外部资助的研究外，这种协作结构将使NTN能够领导CTN内协议未来的发展。该系统还结合了UT西南部的临床前T32和临床R25 NIDA培训补助金，以鼓励CTN内的居民，研究员和教师职业发展，包括K奖。我们的熟练管理团队和UT西南部以前和正在进行的多站点临床试验的培训师将确保协议实施，以及具有重要协作研究经验的CTP站点的干部。 NTN自己的绩效评估系统将协助NTN在开发，实施和传播临床试验结果方面的有效性，这将补充CTN的性能监测器。我们的概念提议提出了一项研究，研究药物算法对使用药物使用和合并症的青少年的影响，揭示了我们节点设计最先进的有效性试验的能力，从而最大程度地提高了CTN框架的潜力。我们认为，NTN的结构和组织及其坚定且经验丰富的研究人员可以补充并扩展了CTN的工作。