The Advanced Clinical Design and Statistical Analysis Core

先进的临床设计和统计分析核心

• 批准号: 8378459
• 负责人: Charles Edward Green
• 金额: $ 18.32万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8378459
• 关键词: Behavioral; Biological Markers; Clinical; Clinical Research; Clinical Trials; Cocaine Dependence; Consultations; Coupled; Development; Drug Addiction; Drug effect disorder; Equation; Evaluation Methodology; Evidence Based Medicine; Funding; Goals; Health Sciences; Methodology; Methods; Modeling; National Institute of Drug Abuse; Nature; Neurobiology; Pharmaceutical Preparations; Pharmacotherapy; Postdoctoral Fellow; Research; Research Design; Students; Substance Addiction; Substance abuse problem; Texas; Training; Translational Research; Universities; cocaine use; design; effective therapy; flexibility; innovation; neurochemistry; novel; patient population

The over-arching goal of the UT Houston Substance Abuse Research-Medication Development Center is to develop safe, effective medications for cocaine dependence. The current Center proposal focuses on elucidating behavioral and neurochemical mechanisms of cocaine dependence and using these findings to guide clinical trials for promising medications. The Advanced Clinical Design and Statistical Analysis Core (ACDSAC) will serve as a critical mechanism for promoting this goal by providing statistical/methodological support for NIDA-funded clinical trials in drug dependence taking place at University of Texas Health Science Center at Houston-Medication Development Center as well as consultation to other NIDA-funded centers. The ACDSAC will accomplish this by: 1) providing support for the design and analysis of conventional clinical trials; 2) advancing utilization of flexible/adaptive study designs for the development of more efficient clinical trials; 3) advancing statistical methodologies for the analysis of clinical trials with a focus on Bayesian modeling and the use of structural equation modeling methodologies for evaluation of mediational hypotheses of drug action. 4) serving as a liaison to the statistical and design divisions of the Center for Clinical Research and Evidence-Based Medicine as well as the Center for Clinical Translational Science, both of the University of Texas Health Science Center at Houston; 5) providing training to post-doctoral staff, fellows and students in study design and advanced quantitative methods; The Advanced Clinical Design and Statistical Analysis Core will advance the overall goal of the UT Houston Medication Development Center by providing advanced novel statistical design and analysis support for medication development clinical trials.

UT休斯顿药物滥用研究中级开发中心的整理目标是 开发可卡因依赖的安全有效药物。当前的中心提议着重于 阐明可卡因依赖性的行为和神经化学机制，并使用这些发现 指导有前途药物的临床试验。高级临床设计和统计分析核心 （ACDSAC）将通过提供统计/方法学来成为促进这一目标的关键机制 支持NIDA资助的药物依赖临床试验，德克萨斯大学健康科学进行了 休斯顿及服务开发中心的中心以及向其他NIDA资助的中心进行咨询。 ACDSAC将通过： 1）为常规临床试验的设计和分析提供支持； 2）推进利用灵活/自适应研究设计，以开发更有效的临床试验； 3）推进统计方法，用于分析临床试验，重点是贝叶斯建模 以及使用结构方程建模方法来评估药物中介假设 行动。 4）作为临床研究中心的统计和设计部门的联络 循证医学以及临床转化科学中心，都 休斯顿的德克萨斯健康科学中心； 5）为研究设计和高级定量的博士后人员，研究员和学生提供培训 方法; 先进的临床设计和统计分析核心将促进UT休斯顿的整体目标 药物开发中心通过提供高级新颖的统计设计和分析支持 药物开发临床试验。