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: 10624966
• 负责人: Chamberlain Obialo
• 金额: $ 99.99万
• 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 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10624966
• 关键词: Academy; Address; Adoption; Affect; African American population; American; Biomedical Research; Black Populations; 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; Institutional Review Boards; Interview; Knowledge; Latinx; Latinx population; Maintenance; Measurement; Medicine; Methods; Modeling; National Center for Advancing Translational Sciences; Needs Assessment; Participant; Patients; Performance; Phase; PhenX Toolkit; Physicians; Policies; Population; Procedures; Process; Protocols documentation; Provider; Public Health; Quasi-experiment; Recommendation; Registries; Reminder Systems; Research; Research Design; Rural Community; Rural Population; Services; Small Business Innovation Research Grant; Surveys; United States National Institutes of Health; Work; budget impact; caucasian American; data integration; design; ethnic minority; experience; feasibility testing; health disparity; implementation study; informant; mortality; pandemic disease; participant interview; patient retention; point of care; post implementation; 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 导致持续的健康差距。美国国家医学院， 组织已经敲响了对临床试验企业影响的警钟， 以及美国人的健康状况。国家科学院建议战略 这将增加在护理点进行临床研究的机会。COVID-19公众 健康流行病揭示了影响美国黑人和 棕色社区，死亡率是白色美国人的2.4到7倍。 目前的疫苗试验招募了不到10%的黑人。这种经历反映了 许多国家卫生研究院的研究机构和中心，以及行业研究。 本SBIR快速通道提案的目标是开发知识、产品和 在真实的实践中实施Health 360 x Platform Service所需的流程 主要服务于非洲裔美国人、拉丁裔和来自农村社区的患者。 我们会落实以下目标： 1)具体目标1-第一阶段。Design Health 360 x临床研究平台（Health 360 x） 2)具体目标2-第二阶段。测试Health 360 x SOP在 三个实践的工作流程，为代表性不足的患者提供服务。 3)具体目标3-第二阶段。评估采用、实施、有效性和 在为代表性不足的患者提供服务的实践中维持健康360 x 主要成果：健康360 x的采用和实施进展， 基于CVIS登记研究方案的性能指标; IRB/知情同意书; PhenX调查的社会决定因素;招聘和保留率;成本分析。 这个快速通道SBIR项目将直接解决NCATS在研究效率方面的优先事项 通过实施商业上可行的临床研究平台， 社区实践设置，并且是可扩展的，以招募，跟踪和留住患者， 在生物医学研究中的代表性不足。