Enhancing Scientific Inquiry in Clinical Neurosciences Through Methodology Traini

通过方法论培训加强临床神经科学的科学探究

• 批准号: 8826835
• 负责人: CHRISTOPHER S. COFFEY
• 金额: $ 46.62万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8826835
• 关键词: Applications Grants; Automobile Driving; Biometry; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collaborations; Conduct Clinical Trials; Data; Development; Disease; Distance Learning; Education; Emergency treatment; Ethics; Evaluation; Face; Foundations; Funding; Future; Goals; Gold; Grant; Health; Injury; Institution; Intervention Studies; Knowledge; Learning; Medical; Mentorship; Methodology; Methods; Monitor; Movement; National Institute of Neurological Disorders and Stroke; Neurologic; Neurological emergencies; Neurosciences; Outcome Measure; Participant; Performance; Persons; Pharmacologic Substance; Phase; Process; Protocols documentation; Reporting; Research; Research Infrastructure; Research Personnel; Residencies; Resources; Selection for Treatments; Stroke; Talents; Testing; Time; Training; Training Programs; United States National Institutes of Health; Universities; Work; base; career development; clinical investigation; design; experience; flexibility; improved; innovation; medical schools; nervous system disorder; next generation; patient oriented; phase III trial; programs; simulation; sound; success; symposium; translational neuroscience; treatment effect; treatment trial; trial design

DESCRIPTION (provided by applicant): Clinical trials are the gold standard method for determining the efficacy of new treatments, yet there are a number of issues inhibiting the pace of discovery in the clinical neurosciences. The result is that many "learn" (phase I/II) clinical trials are failing to move promising treatments forward into "pivotal," confirmatory (phase III) trials in a coherent way. This has led to a high number of confirmatory phase clinical trial failurs and an inability to advance translational neuroscience. Clinical trials are complicated, expensive, and time consuming and many junior investigators working on the development and evaluation of new therapies face substantial barriers to success and progression in the field. With NINDS support, clinical trial networks focused on neuroscience have grown in importance. Analogous to discovery teams within pharmaceutical companies, the NETT Network and NeuroNEXT have created economies of scale with dense cross-university collaborations between clinician trialists, biostatisticians, data managers, monitors, study coordinators and other clinical trial professionals. For this proposal, our overarching goal is to leverage this resource to train the next generation of researchers to deliver the important results from well-designed and scientifically-sound "learn" phase clinical trials that will form the foundation for successful confirmatory trials in the future. Our proposed research educational plan includes pre-conference webinars, an in-person conference, with post-conference webinars and other activities in an integrated, longitudinal, small group experience. An advanced track in clinical trial simulation and flexible adaptive design is planned for the later years. Our approach will allow us to evaluate progress on specific outcome measures (such as number of grants funded) and internal performance metrics (knowledge and competency in clinical trial planning and conduct with course participants). We will use our innovative, cross institutional collaboration to accomplish the following specific aims: 1) Identify promising junior investigators in the clinical neurosciences and provide them with a rigorous foundation in the design, funding, conduct, monitoring/oversight, ethical performance, and reporting of patient-oriented clinical research; 2)Promote ongoing professional career development by supporting participants before, during, and after the course to allow them to follow through on their plans for clinical trials-based research; 3)Enhance the pipeline of scientifically-sound, well-designed early phase clinical investigations that will provide a foundation for pivotal, confirmatory trials to reduce the burden of high-impact neurological diseases; and 4) Create a cooperative infrastructure for collaboration and sharing of educational resources for clinical trialists in the neurosciences to promote scientifically-sound, patient-oriented clinical trials.

描述（由申请人提供）： 临床试验是确定新疗法疗效的金标准方法，但仍有许多问题阻碍了临床神经科学的发现步伐。其结果是，许多“学习”（I/II期）临床试验未能以连贯的方式将有希望的治疗方法推进到“关键的”验证性（III期）试验。这导致了大量的验证性阶段临床试验失败，并且无法推进转化神经科学。临床试验复杂、昂贵且耗时，许多从事新疗法开发和评估的初级研究人员面临着该领域成功和进展的巨大障碍。在NINDS的支持下，专注于神经科学的临床试验网络变得越来越重要。类似于制药公司内部的发现团队，NETT Network和NeuroNEXT通过临床试验人员、生物统计学家、数据管理员、监查员、研究协调员和其他临床试验专业人员之间的密集跨大学合作创造了规模经济。对于这项提案，我们的总体目标是利用这一资源来培训下一代研究人员，以便从精心设计和科学合理的“学习”阶段临床试验中获得重要结果，这将为未来成功的验证性试验奠定基础。我们提出的研究教育计划包括会前网络研讨会，现场会议，会后网络研讨会和其他活动，在一个综合的，纵向的，小组的经验。在临床试验模拟和灵活的自适应设计先进的轨道计划在以后的几年。我们的方法将使我们能够评估具体成果指标（如资助的赠款数量）和内部绩效指标（临床试验规划和与课程参与者进行的知识和能力）的进展。我们将利用创新的跨机构合作， 实现以下具体目标：1）确定临床神经科学中有前途的初级研究者，并为他们提供设计，资助，实施，监测/监督，道德表现和以患者为导向的临床研究报告的严格基础; 2）通过在培训之前、期间、3）加强科学合理、设计良好的早期临床研究的渠道，为关键性、确证性试验提供基础，以减轻负担 4）为神经科学临床试验者建立合作基础设施，以促进科学合理、以患者为导向的临床试验。