Clinical Trials Network: North Texas Node

描述(由申请人提供)： 该应用程序建议一个新的临床试验网络(CTN)节点，代表北得克萨斯州。北德克萨斯节点(NTN)由位于达拉斯的德克萨斯大学西南医学中心(UT Southwest)和位于佛罗里达州达拉斯的七家社区治疗提供者(CTP)组成。沃斯、奥斯汀和埃尔帕索。德克萨斯大学西南分校汇集了一支在物质使用障碍的临床前和临床研究、青少年和成人多点疗效-有效性临床试验的设计、实施和分析、共病障碍的药物治疗以及成瘾的文化问题方面具有丰富经验的教员。德克萨斯大学西南分校的教职员工将与代表每年11,000多名原发药物使用障碍住院和门诊患者的CTP合作，这些患者中有大量西班牙裔/拉丁裔、非裔美国人、青少年和女性患者。CTP和相关网站还为HIV+患者提供专门的治疗和外展计划。NTN采用的行政和组织结构仔细考虑了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。Node的组织也为我们的CTP提供了强有力的声音，确保他们在所有委员会、团队和工作组中的存在。例如，NTN已经启动了开发涉及CTP-UT Southwest联合努力的新方案的机制，正如我们的概念提案所证明的那样，该方案解决了Node的CTP确定的未满足的临床需求。这种协作结构将使NTN能够在CTN内的协议的未来发展方面发挥带头作用，此外，还将进行辅助和外部资助的研究，以最大限度地利用CTN平台。该系统还纳入了德克萨斯大学西南分校的临床前T32和临床R25 NIDA培训补助金，以鼓励住院医师、研究员和教师在CTN内的职业发展，包括K奖项。德州大学西南分校先前和正在进行的多站点临床试验以及具有重要合作研究经验的CTP站点的训练员和管理团队将确保方案的实施。NTN在开发、实施和传播临床试验结果方面的有效性将得到NTN自己的业绩评估系统的协助，该系统将补充CTN的业绩监测。我们的概念提案提出了一项关于药物算法对治疗患有药物使用和共病障碍的青少年的影响的研究，揭示了我们的节点设计最先进的有效性试验的能力，从而最大限度地发挥CTN框架的潜力。我们认为，国家警察的结构和组织，以及其尽职尽责和经验丰富的调查员，是对国家警察工作的补充和扩展。

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.