Clinical Trials Network: North Texas Node

描述（由申请人提供）： 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。北德克萨斯节点（NTN）是由德克萨斯大学西南医学中心在达拉斯（UT西南）和七个社区治疗提供者（CTP）在达拉斯，英尺。沃斯奥斯汀和埃尔帕索UT Southwestern汇集了在物质使用障碍的临床前和临床研究方面具有丰富经验的教师，在青少年和成人中设计，实施和分析多站点，疗效-有效性临床试验，共病疾病的药理学治疗，以及成瘾的文化问题。UT西南部的教师将与代表超过11，000名主要物质使用障碍的年度住院和门诊患者的CTP合作，其中包括大量的西班牙裔/拉丁裔，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联方案。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，以及集中临床、数据管理/统计和后勤中心的启动。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，团队和工作组中的存在。例如，NTN已经启动了开发新协议的机制，这些协议涉及CTP-UT西南部的联合努力，正如我们的概念提案所证明的那样，该提案解决了节点的CTP所确定的未满足的临床需求。除了最大限度地利用CTN平台的辅助和外部资助的研究之外，这种合作结构还将使NTN能够在CTN内未来方案的开发中发挥带头作用。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CTN内，包括K奖。方案的实施将由我们非常熟练的管理团队和来自UT Southwestern以前和正在进行的多中心临床试验的培训师以及具有重要合作研究经验的CTP中心的干部来保证。新界北总医院在发展、推行和公布临床试验结果方面的成效，将由新界北总医院本身的表现评估制度协助，该制度将与新界北总医院的表现监察制度相辅相成。我们的概念提案提出了一项关于药物算法治疗青少年物质使用和共病疾病的影响的研究，揭示了我们的节点设计最先进的有效性试验的能力，最大限度地发挥了CTN框架的潜力。我们相信NTN的结构和组织，以及其致力于和经验丰富的调查人员，补充和扩展了CTN的工作。

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.