Core B: Clinical Translational Core

核心 B：临床转化核心

基本信息

批准号：
10238632
负责人：
ALEXANDER G BASSUK
金额：
$ 24.52万
依托单位：
UNIVERSITY OF IOWA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-16 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10238632
关键词：
Address Adolescence Adult Affect Age Architecture Area Basic Science Bioinformatics Biology Caregivers Caring Clinic Clinical Clinical Data Clinical Research Clinical Trials Collaborations Conceptions Consent Control Groups Country Data Data Mart Development Diagnosis Etiology Family Funding Genetic study Geography Hand Hawks Healthcare Systems Individual Infrastructure Inpatients Intellectual and Developmental Disabilities Research Centers Intellectual functioning disability International Intervention Iowa Laboratories Life Longevity Mental disorders Mission Molecular Outcomes Research Participant Patient Recruitments Patients Personal Satisfaction Pharmaceutical Preparations Population Population Heterogeneity Pregnancy Pregnancy Outcome Prevention Primary Health Care Provider Puberty Research Research Infrastructure Research Personnel Resistance Resources Risk Assessment Role Rural Rural Population Schools Services Site Source Testing Translating Translational Research Underserved Population Universities Work adverse pregnancy outcome autism spectrum disorder biobank care systems clinical practice cohort cost effective critical period data access design electronic consent human subject improved novel organizational structure patient population perinatal period prenatal prospective recruit research clinical testing research study rural area rural underserved urban area

项目摘要

PROJECT SUMMARY: CLINICAL TRANSLATIONAL CORE (CTC) The Clinical Translational Core (CTC) of the Hawk-IDDRC seeks to address the challenges faced by those living with IDD at all life stages by providing investigators the resources to transition discoveries from the laboratory into clinical practice, and enable an understanding of the biology underlying clinical observations, in order to advance translational research. The CTC differentiates itself by providing infrastructure for recruiting rural populations as well as participants at key transition points across the lifespan, including: the perinatal period, puberty and adolescence, adulthood at varying levels of independence, and later adulthood as professional caregivers assume a primary role. These transition points represent critical periods that influence the long-term wellbeing of those living with IDD, yet our understanding of each is limited. Importantly, rural populations 1) have decreased access to appropriate care, 2) have different potential IDD exposures that are not well studied, and 3) lack research infrastructure. The Hawk-IDDRC CTC is poised to fill these needs and will thus provide access to unique clinical data and biosamples from this understudied population by carrying out the following aims: 1) Facilitate and accelerate the recruitment and clinical evaluation of IDD-affected patients at all stages of life and from diverse areas to connect them and their families with clinical studies and resources; 2) Provide IDD researchers with biobanking and bioinformatics services; 3) Facilitate and support the design, development, and testing of novel IDD therapies by providing a successful architecture for clinical trials and drug manufacturing services to IDD researchers. The expertise and resources of the CTC Co- Directors (Mark Santillan and Alexander Bassuk) covers a broad spectrum of capabilities, ranging from prenatal risk assessment, to human subject recruitment, and banking of clinical data and biosamples. Specific assets of the University of Iowa (UI) that cover the lifespan include CoLab (Global Pregnancy Collaboration), an international collaboration of 40 sites focused on pregnancy outcome research, sharing clinical data and biosamples; a clinical recruitment center for SPARK, a nationwide genetic study of autism; UI-led statewide networks of collaborating clinics, schools, and providers in rural and urban areas; and the Intellectual Disability- Mental Illness (ID-MI) clinic, one of only a handful of inpatient units in the country that focuses on patients with intellectual disability and a co-occurring mental illness. The CTC will serve as a central focal point for these resources, streamlining access for investigators, and enabling its support of 31 federally funded projects totaling $12.6 million per year. The access to a unified, harmonized source of clinical data, biosamples, and clinical cohorts allows the CTC to work with all Cores to perform retrospective and prospective IDD studies. The resources of the CTC will support the mission of the Hawk-IDDRC to provide an organizational structure that integrates basic and clinical research across the lifespan—from conception to adulthood—focused on the prevention, diagnosis, treatment and amelioration of IDDs, and tailored to a rural, underserved population.

项目摘要：临床转化核心 (CTC) Hawk-IDDRC 的临床转化核心 (CTC) 旨在解决这些患者面临的挑战通过为研究人员提供将发现从实验室进入临床实践，并能够理解临床观察背后的生物学，为了推进转化研究，CTC 通过提供招募基础设施而脱颖而出。农村人口以及生命周期关键过渡点的参与者，包括：时期、青春期和青春期、处于不同独立水平的成年期以及成年后期专业护理人员发挥主要作用，这些过渡点代表了影响的关键时期。患有 IDD 的人的长期福祉，但我们对每个人的了解都很有限，重要的是，农村。人群 1) 获得适当护理的机会减少，2) 具有不同的潜在 IDD 暴露，没有得到充分研究，3) 缺乏研究基础设施 Hawk-IDDRC CTC 已准备好满足这些需求。因此，将通过携带来自该被研究人群的独特临床数据和生物样本实现以下目标： 1) 促进和加速受 IDD 影响的招募和临床评估来自不同领域、生命各个阶段的患者，将他们及其家人与临床研究联系起来，资源；2) 为 IDD 研究人员提供生物样本库和生物信息学服务；3) 提供便利和支持；通过为临床提供成功的架构来设计、开发和测试新型 IDD 疗法 CTC Co- 的专业知识和资源。董事（Mark Santillan 和 Alexander Bassuk）涵盖广泛的能力，包括产前风险评估、人类受试者招募以及临床数据和生物样本的存储。爱荷华大学 (UI) 覆盖生命周期的资产包括 CoLab（全球妊娠合作）、 40 个站点的国际合作，专注于妊娠结果研究、共享临床数据和生物样本；SPARK 临床招募中心，一项由 UI 主导的联邦自闭症基因研究；农村和城市地区的合作诊所、学校和服务提供者网络；精神疾病 (ID-MI) 诊所是该国少数几家专注于治疗患有精神疾病的患者的住院单位之一 CTC 将作为这些问题的中心焦点。资源，简化调查人员的访问，并使其能够支持 31 个联邦资助的项目每年总计 1260 万美元。临床队列允许 CTC 与所有核心合作进行回顾性和前瞻性 IDD 研究。 CTC 的资源将支持 Hawk-IDDDRC 的使命，提供一个组织结构整合了整个生命周期（从受孕到成年）的基础和临床研究，重点关注预防、诊断、治疗和改善 IDD，并针对农村、服务不足的人群进行定制。