Preclinical and Clincial Outcomes

临床前和临床结果

• 批准号: 10675509
• 负责人: Rodney C Samaco
• 金额: $ 10.95万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-22 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10675509
• 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; Training; Translating; Translational Research; Translations; Work; animal data; behavior test; bench to bedside; biobehavior; clinical investigation; clinical outcome assessment; clinical outcome measures; clinical phenotype; clinical translation; 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. .

临床前和临床结局（PCO）核心的主要目标是提供基础设施， 专业知识和资源，以支持跨越动物和人类研究的双向转化工作。 结合动物模型中神经行为工具和神经精神评估方法的专业知识 将确保使用和开发最相关的任务和措施，帮助解决 IDD转化研究的挑战。PCO核心将为研究者提供一系列经验证的 用于啮齿动物和人类的分析，重点是创建翻译管道，以及协调 跨研究测量。此外，PCO核心将提供有关使用额外 行为分析，将允许IDDRC研究人员进行关键的次要或后续研究， 更好地理解任何行为异常的性质检测与一个主要的行为测试电池。的 动物表型分析和临床前终点子核心为研究者提供资源， 在啮齿动物模型中进行跨多个领域的行为评估。这一核心还侧重于发展 用于评估潜在干预措施的稳健临床前结局指标，作为替代终点 潜在疗法的治疗范式。动物表型分型子核心提供高质量、低成本 在啮齿动物模型中进行有效的行为评估，为实验设计和数据提供专家咨询 分析和培训研究人员独立进行行为评估。它还提供教育 关于各种主题和数据分析、技术问题、故障排除和开发新的 作为临床前结果测量的测定。人类表型和神经心理测量子核心 提供神经行为和神经精神评估工具，包括基于神经行为的方法， 结构化临床访谈和基于任务的测量。《公约》提供的一些创新办法， 人类表型分型子核心包括一种新的基于计算机视觉的技术， 面部表情、姿势和凝视（“自动多模式分析”），以及生物行为感测， 超越传统的评估方法。研究者可以获得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 还可以在执行和分析各种任务方面获得培训和/或监督， 保证资源。人类表型分核心还将提供直接服务， 针对IDD中经常流行的精神健康状况的定制表型分析方法。最后，调查人员 可以访问关于建立动物到人类疾病状态模型的咨询，以方便翻译。 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转化研究碘缺乏病。 .