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

摘要 临床试验中少数种族/民族代表性不足一直是一个长期存在的问题。 非洲裔美国人和西班牙裔美国人占临床参与者的不到10%， 尽管约占美国人口的30%。因此，少数 人口承受着健康差距的负担，但通常不会受益于最近的 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， 参与者级别。iSimcha，LLC是一家位于北卡罗来纳州的少数民族小企业， 开发一个多层平台，通过对每个平台进行个性化， 参与者的临床试验之旅，通过调整资源，教育和支持， 在需要他们的地方。该平台独特地结合了基于社区的研究和 医学教育、临床试验发现者应用和普通语言医学研究 通过AI/ML工具自动化信息。我们第一阶段研究的短期目标是 确定临床试验查找器应用程序的设计特征、可接受性和可用性。 我们的长期目标是展示我们平台的成功， 社区医学研究教育通过社交媒体参与驱动， 发现、理解并参加临床试验。第1阶段具体目标： 目标1-通过设计思考会议确定用户需求和兴趣 目标1的结果将是确定特征和技术，以开发3个独特的人物角色 用于用户测试，这是设计思维和移动的应用程序用户测试的标准实践。 目标2-根据用户反馈和启发式测试确定可用性。使用 基于目标1生成的人物角色，原型设计和反馈将由用户完成 访谈检查痛点、需求和心态。可用性将由系统进行评价 通过两次迭代用户测试会话获得可用性得分，以达到最低得分68。 目标3.目标3 -评估和改进医学研究层语言的AI/ML编程 翻译.在使用层数据源训练模型之后，初始模型将迭代以 满足至少75%的记录的Flesch阅读轻松度得分为70的标准，或 上述

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