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

在本提案中，我们将开发ApricityRx - CT（临床试验）解决方案原型， 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。此解决方案连接 患者和肿瘤学家，分别使用面向患者和面向临床的应用程序， 便于远程监控和方便的虚拟护理干预;此外， 无缝集成数据（ePRO和EMR）进行分析，以生成基于证据或基于方案的 咨询，以提高对方案的遵守和护理的一致性。 在三个并行的工作流中，我们将（1）开发新的功能特性， 易于沟通和数据共享，以连接研究参与者和研究团队， 分析洞察力，如“用户喜欢我”的比较，以激励坚持;（2）建立一个 为特定临床试验配置的ApricityRx-CT解决方案;以及（3）进行形成性 原型ApricityRx-CT解决方案的人为因素测试，以证明其安全有效 使用.在这个原型测试过程中，我们还将记录时间和精力要求 以生成对多个临床试验方案的适应性和可扩展性的证据，因此， 适合支持一个广泛的网络（如NCI的癌症临床试验网络）， 不同的同期临床研究。

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.