ISimcha Technology Platform for Recruiting a Diverse Population of Older Adults into Clinical Trials

ISimcha 技术平台，用于招募不同的老年人群进行临床试验

• 批准号: 10761602
• 负责人: Jamerson Brenda
• 金额: $ 41.69万
• 依托单位: ISIMCHA, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10761602
• 关键词: Address; African American population; Artificial Intelligence; Businesses; Clinical Trials; Collaborations; Communication; Communities; Community Health Education; Complex; Computer software; Consent Forms; Curiosities; Data Sources; Development; Education; Elderly; Enrollment; Ethnic Origin; Feedback; Fostering; Funding; Goals; Grant; Health; Hispanic Populations; Individual; Internet; Intervention; Interview; Language; Laws; Longevity; Machine Learning; Maintenance; Medical; Medical Assistance; Medical Education; Medical Research; Minority; Minority Groups; Modeling; Morbidity - disease rate; North Carolina; Outcome; Pain; Participant; Persons; Phase; Population; Population Heterogeneity; Preparation; Race; Racial Equity; Reading; Records; Research; Resources; Science; Surveys; System; Technology; Testing; Theoretical model; Thinking; Training; Translating; Translations; Trust; Underrepresented Minority; Universities; Work; behavior change; clinical trial enrollment; clinical trial participant; clinical trial protocol; clinical trial readiness; clinical trial recruitment; community based research; design; drug development; education research; ethnic minority; experience; health disparity; heuristics; innovation; interest; minority communities; mobile application; novel therapeutics; poor health outcome; prospective; prototype; racial minority; recruit; research and development; social media; success; technology platform; tool; usability

Abstract Underrepresentation of racial/ethnic minorities in clinical trials has been a long-standing problem as African Americans and Hispanics make up less than 10% of participants in clinical trials despite being approximately 30% of the US populations. As a result, minority populations bear the burden of health disparities but do not usually benefit from recent research advancements. Barriers to racial and ethnic underrepresentation in clinical trials is complex, individualized, and requires a solution aimed at clinical trial readiness at the participant level. iSimcha, LLC, a minority owned small business in North Carolina, is developing a multitier platform to that addresses barriers to enrollment by individualizing each participant’s clinical trial journey by aligning resources, education, and support specifically where they are needed. The platform uniquely combines community based research and medical education, a clinical trial finder application and plain language medical research information automated through AI/ML tools. Our short term goal for the Phase 1 research is to determine the design features, acceptance and usability of the clinical trial finder application. Our long term goal is to demonstrate that success of our platform which uniquely combines community medical research education driven via social media engagement with the ability to find, understand and enroll in clinical trials. Phase 1 specific aims: Aim 1- Define user needs and interests through design thinking sessions The outcome of Aim 1 will be to identify features and technology to develop 3 unique personas for user testing as is standard practice for design thinking and mobile app user testing. Aim 2- Determine the usability based on user feedback and heuristic testing. Using the personas that were generated based on Aim 1, prototyping and feedback will be done by user interviews examining pain points, needs and mindset. Usability will be evaluated by system usability score via two iterative user testing sessions to achieve a minimum score of 68. Aim 3. Aim 3 – Evaluate and refine AI/ML programming for medical research lay language translation. After training the model with lay data sources, the initial model will be iterated to meet a criteria of least 75% of records are scored at a Flesch Reading Ease score of 70 or above

抽象的 临床试验中少数族裔/族裔的代表性不足一直是一个长期存在的问题 问题是非裔美国人和西班牙裔在临床参与者中所占比例不到 10% 尽管约占美国人口的 30%，但仍进行了试验。 人口承受着健康差距的负担，但通常不会从最近的政策中受益 研究进展。临床试验中种族和民族代表性不足的障碍。 是复杂的、个性化的，需要一个旨在为临床试验做好准备的解决方案 iSimcha, LLC 是北卡罗来纳州的一家少数股东拥有的小型企业。 开发一个多层平台，通过个性化每个平台来解决注册障碍 通过专门调整资源、教育和支持来调整参与者的临床试验之旅 该平台独特地将基于社区的研究和 医学教育、临床试验查找器应用程序和通俗语言医学研究 我们第一阶段研究的短期目标是通过人工智能/机器学习工具实现信息自动化。 确定临床试验查找器应用程序的设计特征、接受度和可用性。 我们的长期目标是展示我们平台的成功，该平台独特地将 通过社交媒体参与推动社区医学研究教育，并能够 找到、了解并参加第一阶段的具体目标： 目标 1 - 通过设计思维会议定义用户需求和兴趣 目标 1 的结果将是确定开发 3 个独特角色的功能和技术 用于用户测试，这是设计思维和移动应用程序用户测试的标准做法。 目标 2 - 根据用户反馈和启发式测试确定可用性。 基于目标 1 生成的角色、原型设计和反馈将由用户完成 系统将评估痛点、需求和心态的访谈。 通过两次迭代用户测试会话获得可用性评分，最低分数为 68 分。 目标 3. 目标 3 – 评估和完善医学研究非专业语言的 AI/ML 编程 使用非专业数据源训练模型后，初始模型将被迭代。 满足至少 75% 的记录在 Flesch Reading Ease 得分为 70 分的标准，或者 多于