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.

临床翻译核心B将：（1）启用智力和发育障碍（IDD）相关 临床研究，以加快原因，相关的临床特征和新的转化研究 IDD的干预措施； （2）将非传统方法纳入IDD研究，包括务实的临床 学习医疗系统和远程介入研究中的试验以及（3）加强IDD的纳入 通过为调查团队提供必要的工具，人口进行了正在进行的（非IDD）研究 和培训以支持这些人群。这些努力将促进将IDD的人纳入持续的 临床和翻译研究，尤其是在以前被排除的研究中。这 Core的服务包括（1）以目标咨询的形式对IDDRC研究团队的动手支持 量身定制的“条件无关”的范德比尔特资源，例如 招聘创新中心，该中心 为IDD人群的需求实施临床试验的招聘和保留策略； （2） 维护和扩展两个研究注册表，一种用于自闭症谱系障碍，一种用于降低 综合征； （3）关于电子健康记录和遗传数据库的数据拉的咨询； （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）对非IDD研究团队的动手支持，以加强研究，包括修改 IDD人群的电子同意（Econsent）。这些服务都响应研究者需求 以及通过通过传播来增加本地和全国IDD研究的价值的通用 国家网络。总体而言，Core B的服务专注于鼓励非传统研究人员（例如 那些不从事IDD的人）从事IDD研究；启用涉及非传统的研究 参与者（例如，IDD患者通常被排除在正在进行的临床研究之外）；并有助于使用 非传统方法（例如，务实的试验，远程研究）对IDD研究工作。那，核心B 活动使IDD研究能够最佳地从研究设计到招聘/同意，再进行 实施，还扩大了努力，以更适当地代表非IDD中IDD的人 研究。这些活动将加速与IDD相关的发现，这将导致高影响力 干预和治疗，从而改善了IDD和家庭的人的生活。