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

基本信息

批准号：
10515803
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
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-01 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10515803
关键词：
Academy Address Adoption Affect African American population American Americas 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 Institutes 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 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 experience feasibility testing health disparity implementation study informant mortality pandemic disease point of care post implementation practice setting primary outcome recruit research and development retention rate rural dwellers rural patients social determinants sound vaccine trial

项目摘要

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.

缺乏非裔美国人、拉丁裔社区和农村人口的参与导致持续的健康差异。国家医学院和研究。各机构已就临床试验企业受到的影响敲响警钟，以及美国人的整体健康状况，国家科学院提出了策略建议。这将增加 COVID-19 公众获得临床研究的机会。健康大流行揭示了影响美国黑人和黑人的巨大健康差异棕色人种社区的死亡率是美国白人的 2.4 至 7 倍。目前的疫苗试验招募了不到 10% 的黑人。 NIH 跨机构和中心的大量研究以及行业研究。该 SBIR 快速通道提案的目标是开发知识、产品和在现实世界实践中实施 Health 360x 平台服务所需的流程为主要的非裔美国人、拉丁裔和来自农村社区的患者提供服务。我们将实现以下目标： 1）具体目标1-第一阶段。设计Health 360x临床研究平台（Health 360x） 2) 具体目标 2-阶段 II。测试在以下地区实施 Health 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) 具体目标 3-第二阶段。在为代表性不足的患者提供服务的实践中维护健康 360x 主要成果：Health 360x 的采用和实施进展基于 CVIS 注册协议的绩效指标； PhenX 社会决定因素调查；招聘和保留率分析；该快速通道 SBIR 项目将直接解决 NCATS 对研究效率的优先考虑通过实施一个商业上可行的临床研究平台来适应社区实践设置，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代表性不足。