Statistics and Methodology in Clinical Trials

临床试验中的统计和方法

• 批准号: 8107646
• 负责人: SCOTT N COMPTON
• 金额: $ 17.15万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-24 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8107646
• 关键词: Address; Anxiety Disorders; Applications Grants; Area; Award; Biometry; Childhood; Clinical; Clinical Trials; Cognitive; Collaborations; Complex; Confounding Factors (Epidemiology); Data; Data Set; Decision Making; Development; Elements; Evidence based treatment; Funding; Goals; Grant; Individual; Interdisciplinary Study; Intervention; Intervention Studies; Knowledge; Link; Mentored Patient-Oriented Research Career Development Award; Mentors; Methodology; Methods; Modeling; National Institute of Mental Health; Outcome Study; Patient Care; Perception; Positioning Attribute; Principal Investigator; Randomized; Reading; Research; Research Activity; Research Design; Research Methodology; Research Personnel; Research Project Grants; Series; Simulate; Statistical Methods; Supervision; Therapeutic; Time; Training; Treatment outcome; career; career development; comparative treatment; compliance behavior; design; experience; innovation; non-compliance; research and development; skills; statistics; symposium; treatment effect; treatment trial

DESCRIPTION (provided by applicant): It is widely acknowledged there are too few biostatisticians well-trained in the methods and content of psychiatric research. No where is this more true than in the area of pediatric treatment outcome studies. This Mentored Patient-Oriented Research Career Development Award (K23) is designed to provide the candidate, who already has substantial expertise as a pediatric clinical trialist, with advanced training in statistical and research methodology. The overall goal is to establish the candidate as an independent biostatistical investigator who can serve at the interface of research design, implementation, and statistical methods in pediatric interventions research and contribute to the development of new knowledge and new statistical and research methods. Exemplary mentors, with complementary skills, will advise and supervise the candidate's didactic agenda, which includes formal coursework in advanced biostatistics, directed readings, tutorials, and participation in seminars and conferences. Primary sponsor, Dr. Susan Silva, will advise the candidate's training in the area of research design, statistics, and clinical trails management. Co-sponsor, Dr. John March, will provide oversight as the candidate transitions from clinical trialist to an independent investigator with expertise in research design and advanced statistical methods, and will collaborate with the candidate on multiple NIMH- funded trials for which he is the Principal Investigator. Co-sponsors Drs. Satish lyengar, James Rochon, Marie Davidian, and Thomas Ten Have will supervise the candidate's training in advanced data analytic methods related to their area of expertise. The candidate will use available data sets from two NIMH-funded pediatric comparative treatment trials to address research questions that are of direct relevance to clinicians and individuals making decisions regarding patient care. The primary aim of the candidate's research agenda is to apply and extend data analytic methods appropriate for drawing causal inference from complex multisite pediatric comparative treatment trials [e.g., compiler average causal effect (CAGE) and structural mean model (SMM)j. The research plan also focuses broadly on applying advanced quantitative methods for analyzing clinical trials data. These analyses will help the field better understand the essential treatment elements and mechanisms associated with successful evidence-based treatments for pediatric anxiety disorders. The complementary career development and research plans will help position the candidate as an independent biostatistical investigator who will be able to make original and unique contributions in the areas of applied quantitative and clinical trials methodologies and serve as a statistical and methodological consultant to multidisciplinary research teams and make original and unique contributions to the scientific field of applied quantitative methodology and clinical trials methodologies.

描述（由申请人提供）：广泛认可的生物统计学家在精神病研究的方法和内容中训练有素。没有比小儿治疗结果研究领域更真实的。这项受过指导的注重患者研究职业发展奖（K23）旨在为候选人提供已经具有大量专业知识的儿科临床试验者的候选人，并在统计和研究方法方面进行了高级培训。总体目标是将候选人建立为独立的生物统计研究者，他们可以在小儿干预研究中研究，实施和统计方法的界面工作，并为新知识以及新的统计和研究方法的发展做出贡献。具有互补技能的示例性导师将为候选人的教学议程提供建议和监督，其中包括高级生物统计学，定向阅读，教程以及参加研讨会和会议的正式课程。主要赞助商Susan Silva博士将为候选人在研究设计，统计和临床Trails Management领域的培训提供建议。共同发起人约翰·马克（John March）博士将提供监督，作为从临床试验员到具有研究设计和高级统计方法专业知识的独立研究人员的候选人过渡，并将与候选人合作进行多个NIMH资助的试验，他是他是首席研究员。共同赞助商Drs。 Satish Lyengar，James Rochon，Marie Davidian和Thomas Ten将监督候选人在与其专业领域有关的高级数据分析方法中的培训。候选人将使用两个NIMH资助的小儿比较治疗试验中的可用数据集来解决与临床医生和对患者护理做出决定的直接相关的研究问题。候选人研究议程的主要目的是应用和扩展数据分析方法，适合从复杂的多站点小儿比较治疗试验中绘制因果推断[例如编译器平均因果效应（CAGE）和结构平均值（SMM）j。该研究计划还集中于应用高级定量方法来分析临床试验数据。这些分析将有助于该领域更好地了解与儿科焦虑症的成功循证治疗相关的基本治疗元素和机制。互补的职业发展和研究计划将有助于将候选人定位为独立的生物统计研究员，他们将能够在应用定量和临床试验方法的领域做出原始和独特的贡献，并作为多学科研究团队的统计和方法论顾问，并为应用量化方法论和临床方法学的科学领域做出原始和独特的贡献。

项目成果

Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods.

儿童/青少年焦虑多模式研究 (CAMS)：基本原理、设计和方法。

• DOI: 10.1186/1753-2000-4-1
• 发表时间: 2010-01-05
• 期刊: CHILD AND ADOLESCENT PSYCHIATRY AND MENTAL HEALTH
• 影响因子: 5.6
• 作者: Compton, Scott N;Walkup, John T;Albano, Anne Marie;Piacentini, John C;Birmaher, Boris;Sherrill, Joel T;Ginsburg, Golda S;Rynn, Moira A;McCracken, James T;Waslick, Bruce D;Iyengar, Satish;Kendall, Phillip C;March, John S
• 通讯作者: March, John S