Access for All in ALS (ALL ALS) East Clinical Coordinating Center

ALS 所有人 (ALL ALS) 东部临床协调中心

• 批准号: 10878218
• 负责人: Jinsy Andrews
• 金额: $ 1970.85万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-25 至 2024-09-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10878218
• 关键词: Acceleration; Address; Advocacy; Agreement; Alaska; Award; Biological Markers; Blood; Brain; Businesses; Caregivers; Cell Line; Cells; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Collection; Communication; Communities; Complex; Conscious; Contracts; Critical Pathways; Data; Data Collection; Data Coordinating Center; Data Set; Databases; Dedications; Disease; Education; Education and Outreach; Electronics; Enrollment; Ensure; Equity; Fostering; Foundations; Funding; Future; Gene Mutation; General Hospitals; Genes; Genetic Risk; Geographic Locations; Geography; Grant; Growth; Hawaii; Home; Human Resources; Image; Industry; Infrastructure; Institutional Review Boards; Investigation; Lead; Leadership; Link; Longitudinal Studies; Magnetic Resonance Imaging; Maps; Massachusetts; Measures; Mediation; Mentorship; Monitor; Neurologic; Neurosciences; Nonprofit Organizations; Observational Study; Outcome; Outcome Measure; Participant; Peripheral Blood Mononuclear Cell; Persons; Population; Population Heterogeneity; Procedures; Puerto Rico; Readiness; Recommendation; Recording of previous events; Research; Research Institute; Research Methodology; Research Personnel; Risk; Sampling; Scanning; Science; Scientist; Shoulder; Site; Socioeconomic Status; Structure; Time; Training; Underrepresented Minority; Underrepresented Populations; United States; United States National Institutes of Health; Universities; Vendor; Visit; Washington; Work; amyotrophic lateral sclerosis therapy; biobank; career; clinical center; clinical investigation; clinical research site; clinically relevant; community engaged research; community engagement; community science; cultural competence; data harmonization; data portal; digital; diversity and inclusion; drug development; educational atmosphere; empowerment; evidence base; experience; flexibility; health inequalities; high risk; innovation; interest; longitudinal dataset; magnetic resonance imaging biomarker; member; multimodality; open data; operation; outreach; patient engagement; programs; prospective; public-private partnership; repository; response; skills; socioeconomic diversity; socioeconomics; virtual

Modified Project Summary/Abstract Section To address existing challenges in Amyotrophic Lateral Sclerosis (ALS) research, we propose creation of a new national Amyotrophic Lateral Sclerosis (ALS)clinical research consortium, the Access for All in ALS (ALL ALS) Consortium. This new ALL ALS Consortium will operationalize recommendations of the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) Public Private Partnership (PPP) to hasten drug development for ALS. The ALL ALS Program will have two coordinating centers (the ALL ALS East Coordinating Center and the ALL ALS West Coordinating Center) which together will administer and oversee 34 clinical sites across the United States and Puerto Rico. Specifically, the ALL ALS East Coordinating Center will be located at the Neurological Clinical Research Institute (NCRI) of Massachusetts General Hospital, MA, and will administer 15 clinical sites. MGH NCRI brings extensive experience functioning as coordination center and leading scores of high-quality, multi-site ALS observational studies, biobanking projects and clinical trials, in partnership with industry, academic investigators, and not-for-profit research groups. The new ALL ALS Consortium will provide large-scale, centralized, and readily accessible infrastructure for collection and storage of a wide range of data, including longitudinally collected clinical measures and biofluids from 1) people living with ALS, 2) people at genetic risk for developing Amyotrophic Lateral Sclerosis (ALS), and 3) healthy controls. To foster wide representation across populations, data will be collected from both remote and in person visits, and many clinical sites will be located in geographical areas with underrepresented minorities. Furthermore, to facilitate future research and collaboration, data will be collected and harmonized in a single central data portal.

修改后的项目摘要/摘要部分 为了解决肌萎缩侧索硬化症 (ALS) 研究中现有的挑战，我们建议创建一个新的国家肌萎缩侧索硬化症 (ALS) 临床研究联盟，即“全民 ALS (ALL ALS) 联盟”。这个新的 ALL ALS 联盟将实施《加速获得 ALS 关键治疗法案》(ACT for ALS) 公私合作伙伴关系 (PPP) 的建议，以加快 ALS 药物开发。 ALL ALS 计划将设有两个协调中心（ALL ALS 东部协调中心和 ALL ALS 西部协调中心），它们将共同管理和监督美国和波多黎各的 34 个临床中心。具体来说，ALL ALS 东部协调中心将设在马萨诸塞州总医院的神经临床研究所 (NCRI)，并将管理 15 个临床中心。 MGH NCRI 拥有丰富的经验，作为协调中心，并与行业、学术研究人员和非营利研究团体合作，领导了数十项高质量、多地点 ALS 观察研究、生物样本库项目和临床试验。新的 ALL ALS 联盟将提供大规模、集中且易于访问的基础设施，用于收集和存储广泛的数据，包括纵向收集的临床测量数据和生物体液，这些数据来自 1) ALS 患者、2) 有患肌萎缩侧索硬化症 (ALS) 遗传风险的人，以及 3) 健康对照者。为了促进跨人群的广泛代表性，将从远程和亲自访问中收集数据，并且许多临床站点将位于少数族裔代表性不足的地理区域。此外，为了促进未来的研究和协作，数据将在一个中央数据门户中收集和协调。