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.

在此提案中，我们将开发一个原型ApricityRx - CT（临床试验）解决方案作为一种 临床试验参与者开车的创新端到端不良事件管理解决方案 参与，依从性，整体试验参与和健康满意度。该解决方案连接 患者和肿瘤学家面向患者和面向诊所的应用 促进远程监控和方便的虚拟护理干预措施；另外，它可以 无缝集成数据（EPRO和EMR）用于分析以生成基于证据或基于协议的分析 提高遵守协议和护理一致性的咨询。 在三个平行的工作流中，我们将（1）开发用于增强的新功能 沟通和数据共享的便捷性，以将研究参与者和研究团队与 分析见解，例如“像我这样的用户”比较，与依从性的依从性； （2）构建 为特定的临床试验配置的ApricityRX-CT解决方案； （3）进行形成 原型ApricityRx-CT解决方案的人体因子测试，以证明其安全有效 用途。在此原型测试过程中，我们还将记录时间和精力要求 为了产生对多个临床试验方案的适应性和可伸缩性的证据，因此 支持广泛网络（例如NCI的癌症临床试验网络）的适用性 不同的并发临床研究。