SBIR PHASE I- TOPIC 410 - CANCER CLINICAL TRIALS RECRUITMENT AND RETENTION TOOLS FOR PARTICIPANT ENGAGEMENT.

SBIR 第一阶段 - 主题 410 - 癌症临床试验招募和保留参与者参与的工具。

• 批准号: 10269289
• 负责人: LYNDA CHIN
• 金额: $ 39.99万
• 依托单位: APRICITY HEALTH, INC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-16 至 2021-06-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10269289
• 关键词: Adherence; Adverse event; Caring; Clinic; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical trial protocol document; Communication; Data; Detection; Education; Effectiveness; Fast Healthcare Interoperability Resources; Guidelines; Health; Human; Intervention; Intervention Trial; Interview; Knowledge; Modeling; Monitor; Oncologist; Outcome Measure; Participant; Patients; Performance; Phase; Process; Protocols documentation; Reporting; Running; Safety; Small Business Innovation Research Grant; Testing; Therapeutic Intervention; Time; Translating; base; cancer clinical trial; clinical trial participant; dashboard; data sharing; design; evidence base; improved; innovation; insight; novel therapeutic intervention; programs; prototype; recruit; satisfaction; tool; usability; virtual

In this Proposal, we will develop a prototype ApricityRx – CT (clinical trial) solution as an innovative end-to-end adverse event management solution for clinical trial participants to drive engagement, adherence, overall trial participation and health satisfaction. This solution connects patients and oncologists with a patient-facing and a clinic-facing application, respectively, to facilitate remote monitoring and convenient virtual care intervention; in addition, it can seamlessly integrate data (ePRO and EMR) for analyses to generate evidence-based or protocolbased advisory to improve the adherence to protocol and consistency of care. In three parallel workstreams, we will (1) develop new function features geared toward enhancing the ease of communication and data sharing to connect study participants and study team, with analytic insights, such as “user like me” comparison, to motivate adherence; (2) build a ApricityRx-CT solution configured for a specific clinical trial; and (3) conduct a formative human factor test of the prototype ApricityRx-CT solution to demonstrate its safe and effective uses. During this prototype testing process, we will also document time and effort requirement to generate evidence of adaptability and scalability to multiple clinical trial protocols, hence the suitability to support a broad network (such as NCI’s cancer clinical trial network) with hundreds of different concurrent clinical studies.

在本提案中，我们将开发一个原型 ApricityRx – CT（临床试验）解决方案作为 为临床试验参与者提供创新的端到端不良事件管理解决方案 参与度、依从性、总体试验参与度和健康满意度。该解决方案连接 患者和肿瘤学家分别拥有面向患者和面向临床的应用程序 促进远程监控和便捷的虚拟护理干预；此外，它还可以 无缝集成数据（ePRO 和 EMR）进行分析，以生成基于证据或基于协议的数据 提高对方案的遵守和护理一致性的咨询。 在三个并行工作流程中，我们将 (1) 开发新的功能特性，旨在增强 连接研究参与者和研究团队的沟通和数据共享的便利性， 分析见解，例如“像我这样的用户”比较，以激励坚持； (2)建立一个 针对特定临床试验配置的 ApricityRx-CT 解决方案； (3) 进行形成性的 对原型 ApricityRx-CT 解决方案进行人为因素测试，证明其安全有效 用途。在原型测试过程中，我们还将记录时间和精力要求 生成对多种临床试验方案的适应性和可扩展性的证据，因此 适合支持拥有数百个的广泛网络（例如 NCI 的癌症临床试验网络） 不同的同时进行的临床研究。