Core B: Clinical Translational Core

核心 B：临床转化核心

• 批准号: 10229593
• 负责人: BETH A MALOW
• 金额: $ 20.89万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-06 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10229593
• 关键词: Address; Affect; Area; Asthma; Behavior assessment; Blood; Caregivers; Child; Clinical; Clinical Research; Clinical Trials; Consent; Consultations; Data; Data Analyses; Data Science Core; Discipline; Disease; Down Syndrome; Educational Intervention; Educational Materials; Electronic Health Record; Enrollment; Face; Family; Feedback; Future; Genetic Databases; Healthcare Systems; Individual; Intellectual and Developmental Disabilities Research Centers; Intellectual functioning disability; Intervention; Intervention Studies; Learning; Longevity; Maintenance; Medical; Methods; Modeling; Obesity; Outcome; Participant; Patients; Population; Population Study; Pragmatic clinical trial; Preparation; Prevalence; Protocols documentation; Registries; Research; Research Design; Research Personnel; Research Project Grants; Resources; Rural Population; Scanning; Schools; Services; Structure; System; Technology; Testing; Time; Training; Translating; Translational Research; Work; aging population; autism spectrum disorder; base; behavioral phenotyping; community engagement; design; disability; driving force; efficacy evaluation; electronic consent; electronic data; imaging modality; improved; individualized medicine; innovation; neurophysiology; novel; novel strategies; pragmatic trial; public health relevance; recruit; remote intervention; research study; response; retention rate; targeted treatment; telehealth; tool; translational neuroscience; translational study; vaccine trial

The Clinical Translational Core B will: (1) enable intellectual and developmental disabilities (IDD)-related clinical research to accelerate translational studies of the causes, associated clinical features, and new interventions in IDD; (2) incorporate non-traditional approaches into IDD research, including pragmatic clinical trials within learning healthcare systems and remote interventional studies and (3) enhance inclusion of IDD populations into ongoing (non-IDD) research studies by providing investigative teams with the necessary tools and trainings to support these populations. These efforts will facilitate inclusion of people with IDD into ongoing clinical and translational research, especially in studies from which they have previously been excluded. The Core’s services include (1) hands-on support to IDDRC research teams in the form of targeted consultations that tailor “condition-agnostic” Vanderbilt resources such as the Recruitment Innovation Center, which implements recruitment and retention strategies for clinical trials, to the needs of IDD populations; (2) maintenance and expansion of two research registries, one for autism spectrum disorder and one for Down syndrome; (3) consultation on data pulls for electronic health records and genetic databanks; (4) various methods to enable remote research, including online research portals and telehealth research approaches; and (5) hands-on support to non-IDD research teams to enhance inclusion in studies, including modifying Electronic Consent (eConsent) for IDD populations. These services are both responsive to investigator needs as well as generative in adding value to IDD research locally and nationwide, via dissemination through national networks. Overall, Core B’s services are focused on encouraging non-traditional researchers (e.g. those not working on IDD) to become engaged in IDD research; enables research involving non-traditional participants (e.g. people with IDD typically excluded from ongoing clinical research); and facilitates the use of non-traditional approaches (e.g. pragmatic trials, remote research) into IDD research efforts. Thus, Core B’s activities enable IDD research to be conducted optimally from study design to recruitment/consent, to implementation, and also expands efforts to more appropriately represent those with IDD in non-IDD ongoing research studies. Together these activities will accelerate IDD-related discoveries that will lead to high-impact interventions and treatments, thus improving the lives of those with IDD and families.

临床转化核心B将：（1）使智力和发育障碍（IDD）相关 临床研究，以加速对病因、相关临床特征和新的 （2）将非传统方法纳入碘缺乏病研究，包括实用的临床 在学习型医疗保健系统和远程干预研究中进行试验，以及（3）提高IDD的纳入率 通过向调查小组提供必要的工具， 和培训来支持这些人群。这些努力将有助于将缺碘症患者纳入正在进行的 临床和转化研究，特别是在他们以前被排除在外的研究中。的 该中心的服务包括：（1）以有针对性的咨询形式，向非洲荒漠化问题和防治荒漠化中心的研究小组提供实际支助 定制“条件不可知”的范德比尔特资源，如 招聘创新中心， 实施临床试验的招募和保留策略，以满足IDD人群的需求;（2） 维持和扩大两个研究登记处，一个是自闭症谱系障碍，另一个是唐氏症 综合征;（3）电子健康记录和基因数据库数据提取咨询;（4）各种 实现远程研究的方法，包括在线研究门户和远程保健研究方法; 及（5）为非缺碘症研究队伍提供实际支援，以提高研究的包容性，包括修改 IDD人群的电子同意书（eConsent）。这些服务都是为了满足研究者的需求 以及通过以下方式传播，为地方和全国的缺碘症研究增加价值 国家网络。总的来说，核心B的服务重点是鼓励非传统的研究人员（例如， 不从事碘缺乏病研究的人）从事碘缺乏病研究;使研究能够涉及非传统的 参与者（例如，通常被排除在正在进行的临床研究之外的IDD患者）;并促进使用 在缺碘症研究工作中采用非传统方法（例如，实用试验、远程研究）。因此，核心B的 活动使IDD研究能够从研究设计到招募/同意以最佳方式进行， 还扩大努力，更适当地代表非缺碘症患者 研究。这些活动将加速与缺碘症有关的发现， 这些措施和治疗，从而改善缺碘症患者及其家庭的生活。