Health 360x Clinical Research Platform for Scalable Access to Clinical Trials

Health 360x 临床研究平台可扩展临床试验的访问

• 批准号: 10258627
• 负责人: Chamberlain Obialo
• 金额: $ 32.5万
• 依托单位: ACCUHEALTH TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258627
• 关键词: Academy; Address; Adoption; Affect; African American; American; Americas; Biomedical Research; COVID-19; Cardiovascular system; Categories; Clinical Research; Clinical Trials; Communication; Communities; Community Practice; Consent; Cost Analysis; Cues; Data; Data Analytics; Data Collection; Effectiveness; Enrollment; Focus Groups; Goals; Health; Industry; Informed Consent; Institutes; Institutional Review Boards; Interview; Knowledge; Latinx; Maintenance; Measurement; Medicine; Methods; Modeling; Needs Assessment; Participant; Patients; Performance; Phase; PhenX Toolkit; Physicians; Policies; Population; Procedures; Process; Protocols documentation; Provider; Public Health; Quasi-experiment; Registries; Reminder Systems; Research; Research Design; Rural Community; Rural Population; Services; Small Business Innovation Research Grant; Surveys; Time; United States National Institutes of Health; Work; base; budget impact; caucasian American; data integration; design; ethnic minority population; experience; feasibility testing; health disparity; implementation study; informant; mortality; pandemic disease; point of care; practice setting; primary outcome; recruit; research and development; retention rate; rural dwellers; rural patients; social determinants; sound; vaccine trial

Lack of participation of African-Americans, Latinx communities and rural populations leads to persistent health disparities. The National Academy of Medicine, and research organizations have sounded the alarm about the impact on the clinical trial enterprise, and the health of Americans in general. The national Academy recommends strategies that will increase access to clinical research at the point of care. The COVID-19 public health pandemic has revealed significant health disparities affecting America’s black and brown communities, with 2.4 to 7 times mortality rates compared to white Americans. Current vaccine trials have enrolled less than 10% Blacks. This experience mirrors numerous NIH studies across institutes and centers, as well as industry studies. The goal of this SBIR Fast-Track proposal is to develop the knowledge, products and processes needed to implement Health 360x Platform Service in real world practices serving predominant African Americans, Latinx, and patients from rural communities. We will implement the following aims: 1)Specific Aim 1-Phase I. Design Health 360x Clinical Research Platform (Health 360x) 2) Specific Aim 2-Phase II. Test the feasibility of implementing Health 360x SOP in the workflow of three practices, serving under-represented patients. 3)Specific Aim 3-Phase II. Evaluate the adoption, implementation, effectiveness, and maintenance of Health 360x in practices serving under-represented patients Primary outcome: Adoption and implementation progress of Health 360x with performance indicators based on the CVIS Registry protocol; IRB/informed consent; PhenX surveys for social determinants; Recruitment and Retention rates; Cost analysis. This Fast-Track SBIR project will directly address NCATS priority on research efficiency by implementing a commercially viable clinical research platform that adapts to community practice settings, and is scalable, to recruit, track and retain patients who are under represented in biomedical research.

非裔美国人，拉丁裔社区和农村人口缺乏参与 导致持续的健康差异。国家医学院和研究 组织对临床试验企业的影响发出了警报， 以及美国人的健康。美国国家学院推荐策略 这将在护理点增加获得临床研究的机会。共同-19公众 健康大流行揭示了影响美国黑人和 棕色社区，与美国白人相比，死亡率为2.4至7倍。 当前的疫苗试验招募了不到10％的黑人。这种体验镜子 跨学院和中心以及行业研究的许多NIH研究。 该SBIR快速轨道建议的目的是发展知识，产品和 在现实世界实践中实施健康360X平台服务所需的过程 为来自农村社区的主要非裔美国人，拉丁裔和患者服务。 我们将实施以下目标： 1）特定的目标1期I.设计健康360X临床研究平台（健康360X） 2）特定的目标2相III。测试实施健康360X SOP的可行性 三种实践的工作流程，为代表性不足的患者提供服务。 3）特定的目标3相II。评估采用，实施，有效性和 维持健康360X的实践，为代表性不足的患者提供服务 主要结果：健康360X的采用和实施进展 基于CVIS注册表协议的性能指标； IRB/知情同意； 对社会决定者的苯苯第二调查；招聘和保留率；成本分析。 这个快速轨道SBIR项目将直接解决研究效率的NCAT优先级 通过实施一个可行的可行的临床研究平台，以适应 社区练习环境，并且是可扩展的，可招募，跟踪和保留那些 在生物医学研究中代表。