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

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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.