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

非洲裔美国人、拉丁裔社区和农村人口缺乏参与 导致持续的健康差距。美国国家医学和研究学院 组织对临床试验企业的影响敲响了警钟， 以及总体上美国人的健康。美国国家科学院建议战略 这将增加在护理阶段进行临床研究的机会。新冠肺炎公众 健康大流行暴露出显著的健康差距，影响着美国黑人和 棕色社区，死亡率是美国白人的2.4到7倍。 目前的疫苗试验只招募了不到10%的黑人。这一经历反映了 许多研究所和中心的NIH研究，以及行业研究。 该SBIR快速通道计划的目标是开发知识、产品和 在实际实践中实施Health 360x平台服务所需的流程 为主要的非裔美国人、拉丁裔美国人和来自农村社区的患者服务。 我们将落实以下目标： 1)明确目标一期设计健康360x临床研究平台(健康360x) 2)具体目标2-阶段2.测试健康360x标准作业程序在 三个实践的工作流程，服务于代表不足的患者。 3)具体目标3--第二阶段。评估采用、实施、有效性和 在为代表不足的患者提供服务的实践中保持健康360倍 主要成果：通过和实施Health 360 x的进展情况 基于CVIS注册协议的业绩指标；IRB/知情同意； 社会决定因素的PhenX调查；招聘和保留率；成本分析。 该快速通道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来适应 社区实践设置，并可扩展，以招募、跟踪和保留符合以下条件的患者 在生物医学研究中的代表性不足。

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.