Child and Adolescent Psychiatry Trials Network (CAPTN)

描述（由申请人提供）：响应PAR-01-089高级干预和服务研究中心（ACISR），杜克临床研究所（DCRI）与美国儿童和青少年精神病学学会（AACAP）合作，提议开发一个创新的大型，简单的“务实”试验网络，儿童和青少年精神病学试验网络（CAPTN）。CAPTN的总体目标是提供可靠的心理健康结果估计，适用于在常规临床条件下接受治疗的广大患者。在CAPTN参与者和代表该领域主要利益相关者的指导委员会的指导下，我们以两个至关重要的临床问题为起点：(1)广泛使用的单一和联合药物治疗缺乏随机证据；(2)单一和多种药物的长期安全性。CAPTN将作为DCRI的一个中心运作，DCRI是一个经验丰富的学术研究机构，在临床试验协调方面拥有丰富的经验。运营核心提供全面的行政领导、项目管理、现场管理、数据管理和统计服务，以及对职业发展和临床研究培训计划的行政监督。方法核心选择要解决的问题，并提供研究设计，临床试验方法学，实践研究，临床评估，生物信息学和数据分析技术方面的专业知识。试验核心侧重于发展将由该网络进行的具体试验。网络核心与AACAP协同工作，提供网络的开发和扩展。每年有200到400名儿童和青少年精神病学家参加两到四个随机对照试验，CAPTN制定了国家心理健康咨询委员会（NAMHC）临床治疗和服务研究工作组的建议，以制定“提高相关性，加速发展，并促进将基于研究的精神疾病治疗和服务干预纳入常规临床实践和指导我们地方和国家精神卫生服务系统的政策。”

DESCRIPTION (provided by applicant): Responding to PAR-01-089 for Advanced Centers for Interventions and Services Research (ACISR), the Duke Clinical Research Institute (DCRI) in concert with the American Academy of Child and Adolescent Psychiatry (AACAP) propose to develop an innovative large, simple "pragmatic" trials network, the Child and Adolescent Psychiatry Trials Network (CAPTN). The overall goal of CAPTN is to provide reliable estimates of mental health outcomes applicable to a broad patient base treated under usual clinical conditions without bias. Guided by CAPTN participants and a Steering Committee representing the major stakeholders in the field, we take as our starting place two critically important clinical issues: (1) widely used single and combined drug treatments for which randomized evidence is absent and (2) the long-term safety of mono and polypharmacy. CAPTN will operate as a Center within the DCRI, an experienced academic research organization with extensive experience in clinical trials coordination. Four Cores are proposed: The Operations Core provides overall administrative leadership, project management, site management, data management, and statistical services, as well as administrative oversight of the career development and clinical research training program. The Methods Core selects the questions to be addressed and provides expertise in research design, clinical trial methodology, practice research, clinical assessment, bioinformatics, and data analytic techniques. The Trials Core focuses on the development of specific trials to be conducted by the Network. Working with the AACAP, the Network Core provides for the development and expansion of the network. With 200 to 400 child and adolescent psychiatrists each participating in two to four randomized controlled trials per year, CAPTN enacts recommendations of the Clinical Treatment and Services Research Workgroup of the National Advisory Mental Health Council (NAMHC) to develop "strategies for increasing the relevance, speeding the development, and facilitating the utilization of research-based treatment and service interventions for mental illnesses into both routine clinical practice and policies guiding our local and national mental health service systems."