Core B: Clinical Translational Core

核心 B：临床转化核心

• 批准号: 10686006
• 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/10686006
• 关键词: Acceleration; 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; Education; Educational Intervention; Educational Materials; Electronic Health Record; Enrollment; Exclusion; 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; Medical Research; Methods; Modeling; Obesity; Outcome; Participant; Patients; Persons; 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; Training; Training and Education; Translating; Translational Research; Work; aging population; autism spectrum disorder; behavioral phenotyping; clinical translation; community engagement; design; disability; driving force; education research; 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) 实现与智力和发育障碍 (IDD) 相关的障碍 临床研究，以加速病因、相关临床特征和新发现的转化研究 对 IDD 的干预； (2) 将非传统方法纳入IDD研究，包括实用的临床方法 学习型医疗保健系统和远程干预研究中的试验，以及 (3) 加强 IDD 的包容性 通过为调查团队提供必要的工具，让人们参与正在进行的（非 IDD）研究 以及为这些人群提供支持的培训。这些努力将有助于将 IDD 患者纳入持续的治疗中 临床和转化研究，尤其是之前被排除在外的研究。这 Core 的服务包括 (1) 以针对性咨询的形式为 IDDRC 研究团队提供实际支持 定制“与条件无关”的范德比尔特资源，例如 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) 维护和扩大两个研究登记处，一个用于自闭症谱系障碍，一个用于唐氏综合症 综合症; （三）电子健康档案、基因数据库数据拉取咨询； (4)各种 实现远程研究的方法，包括在线研究门户和远程医疗研究方法； (5) 为非 IDD 研究团队提供实际支持，以增强研究的包容性，包括修改 IDD 人群的电子同意书 (eConsent)。这些服务都满足调查人员的需求 以及通过传播为当地和全国范围内的 IDD 研究增加价值 全国网络。总体而言，Core B 的服务侧重于鼓励非传统研究人员（例如 那些不从事 IDD 工作的人）从事 IDD 研究；使研究涉及非传统 参与者（例如，患有 IDD 的人通常被排除在正在进行的临床研究之外）；并方便使用 IDD 研究工作的非传统方法（例如实用试验、远程研究）。因此，核心 B 活动使 IDD 研究能够以最佳方式进行，从研究设计到招募/同意，再到 实施，并加大力度，在正在进行的非 IDD 活动中更恰当地代表 IDD 患者 研究。这些活动将共同加速 IDD 相关的发现，从而带来高影响力 干预和治疗，从而改善 IDD 患者及其家人的生活。