Preclinical and Clincial Outcomes

临床前和临床结果

• 批准号: 10085947
• 负责人: Rodney C Samaco
• 金额: $ 10.94万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 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/10085947
• 关键词: Address; Animal Behavior; Animal Model; Animals; Assessment tool; Back; Basic Science; Behavior assessment; Behavioral; Behavioral Assay; Biological Assay; Clinical; Clinical Investigator; Clinical Trials; Clinical assessments; Cognitive; Computer Vision Systems; Consultations; Core Facility; Data Analyses; Development; Disease; Disease model; Educational workshop; Ensure; Evaluation; Experimental Designs; Facial Expression; Faculty; Fee-for-Service Plans; Follow-Up Studies; Future; Goals; Human; Industry Standard; Infrastructure; Intellectual and Developmental Disabilities Research Centers; Intervention; Interview; Longevity; Measures; Medicine; Mental Health; Methods; Modality; Modeling; Nature; Neurologic; Neuropsychology; Outcome; Outcome Assessment; Outcome Measure; Patients; Phenotype; Physiological; Posture; Preclinical Testing; Protocols documentation; Questionnaires; Reproducibility; Research; Research Personnel; Resources; Rodent; Rodent Model; Science; Service delivery model; Services; Structure; Supervision; Surrogate Endpoint; Techniques; Testing; Time; Training; Translating; Translational Research; Translations; Work; animal data; base; behavior test; bench to bedside; biobehavior; clinical investigation; clinical phenotype; college; cost effective; design; experimental study; flexibility; gaze; human data; human model; human subject; innovation; investigator training; multimodality; neurobehavioral; neuropsychiatry; novel; novel strategies; novel therapeutic intervention; novel therapeutics; pre-clinical; quality assurance; social; tool; translational pipeline

The primary goal of the Preclinical & Clinical Outcomes (PCO) Core is to provide the infrastructure, expertise and resources to support bi-directional translational efforts spanning animal and human research. Combining the expertise of neurobehavioral tools in animal models and neuropsychiatric assessment methods in humans will ensure the use and development of maximally relevant tasks and measures, helping to address challenges in translational research in IDD. The PCO Core will provide investigators with a battery of validated assays for rodents and humans, with a focus on creating a translational pipeline, as well as harmonizing measures across studies. In addition, the PCO Core will provide access and training on the use of additional behavioral assays that will allow IDDRC investigators to perform critical secondary or follow-up studies to better understand the nature of any behavioral abnormality detected with a primary behavioral test battery. The Animal Phenotyping & Preclinical Endpoints sub-core provides resources for investigators to perform behavioral assessment across various domains in rodent models. This core also focuses on development of robust preclinical outcome measures for assessment of potential interventions, serving as surrogate endpoints in treatment paradigms for potential therapies. The animal phenotyping sub-core provides high quality, cost effective behavioral assessments in rodent models, expert consultation for experimental design and data analysis and training investigators to conduct behavior assessments independently. It also offers educational workshops on various topics and data analysis, technical issues, trouble-shooting and development of novel assays as preclinical outcome measures. The Human Phenotyping and Neuropsych Measures sub-core provides neurobehavioral and neuropsychiatric assessment tools, comprising questionnaire-based methods, structured clinical interviews, and task-based measures. Some of the innovative approaches provided by the human phenotyping sub-core includes a novel computer vision-based technique for quantifying dynamics of facial expression, posture, and gaze ("automated multimodal analysis"), and bio-behavioral sensing, to move beyond traditional assessment approaches. Investigators can access consultation and guidance regarding developing phenotyping batteries, which may involve the creation or utilization of novel approaches. They can also access training and/or supervision in implementing and analyzing varied tasks, together with quality assurance resources. The human phenotyping sub-core will also provide direct service in implementing tailored phenotyping approaches for mental health conditions frequently prevalent in IDD. Finally, investigators can access consultation regarding building animal to human models of disease state to facilitate translation. Thus, the PCO Core's set of unique resources and broad expertise provides IDDRC Investigators a cost- effective and flexible means for conducting cross-species translational research in IDD. .

临床前和临床结果(PCO)核心的主要目标是提供基础设施， 支持跨越动物和人类研究的双向翻译努力的专业知识和资源。 结合动物模型中的神经行为工具和神经精神病学评估方法的专业知识 将确保使用和发展最相关的任务和措施，帮助解决 IDD翻译研究面临的挑战。PCO核心将为调查人员提供一组经过验证的 啮齿动物和人类的检测，重点是建立一个翻译管道，以及协调 跨研究的衡量标准。此外，私隐专员公署核心将提供有关使用其他 将允许IDDRC调查人员执行关键的二次或后续研究的行为分析 更好地了解使用初级行为测试组合检测到的任何行为异常的性质。这个 动物表型和临床前终结点分核心为研究人员提供了执行 啮齿动物模型中不同领域的行为评估。这一核心还侧重于 作为替代终点的用于评估潜在干预措施的稳健的临床前结果衡量标准 在潜在疗法的治疗范例中。动物表型亚核提供了高质量、高成本 啮齿动物模型的有效行为评估，实验设计和数据的专家咨询 分析和培训调查人员独立进行行为评估。它还提供了教育 关于各种主题和数据分析、技术问题、故障排除和小说开发的讲习班 化验作为临床前结果衡量标准。人类表型和神经心理测量分核心 提供神经行为和神经精神评估工具，包括基于问卷的方法， 有组织的临床访谈和基于任务的措施。提供的一些创新方法 人类表型分型亚核心包括一种新的基于计算机视觉的技术，用于量化 面部表情、姿势和凝视(自动多模式分析)，以及生物行为感知，以移动 超越了传统的评估方法。调查人员可以访问有关以下方面的咨询和指导 开发表型电池，这可能涉及创造或利用新的方法。他们可以 还可以获得执行和分析各种任务以及质量方面的培训和/或监督 保证资源。人类分型分核心还将在执行 针对精神健康状况的定制表型方法在IDD中经常流行。最后，调查人员 可以获得关于建立疾病状态的动物到人类模型的咨询，以便于翻译。 因此，PCO核心的一套独特的资源和广泛的专业知识为IDDRC调查人员提供了成本- 有效和灵活的手段进行跨物种的IDD翻译研究。 。