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Preclinical and Clincial Outcomes

临床前和临床结果

基本信息

批准号：
10427286
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
项目类别：
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/10427286
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 outcome assessment clinical outcome measures 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

项目摘要

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，