Clinical Trials Network: North Texas Node

本申请提出了一个新的临床试验网络（CTN）节点，代表北德克萨斯州。北德克萨斯 Node（NTN）由位于达拉斯的德克萨斯大学西南医学中心（TIT西南）组成， 七个社区治疗提供者（CTPs）在达拉斯，英尺。沃斯奥斯汀和埃尔帕索UT西南带来 在药物滥用的临床前和临床研究方面具有丰富经验的教师，设计， 在青少年和成人中进行的多中心、疗效-有效性临床试验的实施和分析， 共病疾病的药物治疗和成瘾的文化问题。UT西南学院将 与代表每年超过11，000名主要药物使用住院和门诊患者的CTP合作 疾病，有大量的西班牙裔/拉丁美洲人、非洲裔美国人、青少年和女性患者。现金转拨方案和 相关站点还为艾滋病毒阳性患者提供专门的治疗和外展方案。 NTN采用的行政和组织结构仔细考虑了CTN的结构， 政策和程序，以及启动集中的临床、数据管理/统计和后勤中心。 该节点的组织还为我们的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。例如，NTN已经启动了制定新协议的机制，其中涉及联合CTP- UT西南部的努力，正如我们的概念提案所证明的那样，该提案解决了由 Node的CTP。这个合作架构将使新界北在发展未来 除了辅助和外部资助的研究，CTN内的协议，最大限度地提高了CTN平台。这 该系统还结合了UT西南的临床前T32和临床R25 NIDA培训赠款，以鼓励 居民，研究员，和教师的职业发展在CTN，includingK奖。方案实施将 由我们非常熟练的管理团队和培训师从UT西南的以前和正在进行的保证 多中心临床试验和具有重要合作研究经验的CTP中心骨干。 NTN在开发、实施和传播临床试验结果方面将得到NTN自身的协助， 业绩评估系统，这将补充CTN的业绩监测。我们的ConceptProposal， 该研究提出了一项关于药物治疗算法对治疗青少年药物使用和共病的影响的研究。 疾病，揭示了我们的节点的能力，设计国家的人工有效性试验，最大限度地发挥潜力， CTN框架。我们相信NTN的结构和组织，以及它的承诺和高度 经验丰富的调查员，补充和扩展CTN的工作。

This application proposes a new ClinicalTrials Network(CTN) node representing North Texas. The North Texas Node (NTN) is comprised of the University of Texas Southwestern Medical Center in Dallas (TIT Southwestern) and seven Community Treatment Providers (CTPs) in Dallas, Ft. Worth, Austin,and El Paso. UT Southwesternbrings together a faculty with extensive experience in the preclinical and clinical study of substance u&edisorders, 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 clinicalneed 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, includingK 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 disseminatingthe results of clinicaltrials will be assisted by the NTN's own Performance Assessment System, which will complement the CTN's performance monitors. Our ConceptProposal, 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-arteffectiveness 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.