Case study: best practices in applying rapid prototyping to inform both protocol design and patient engagement in clinical trials

Jeremy Sohn


With increasing attention being paid to patient centricity and implications for protocol design, sponsors are incorporating many innovative approaches to improving the participant experience during a clinical trial. Mobile patient engagement platforms are a key element to this strategy. Such platforms offer a myriad of features to better engage patients, including contextually relevant access to content, compliance and med adherence tools, patient diaries, site communication tools, and enhanced data capture and PROs. Mobile patient engagement platforms, or maybe better yet, mobile patient-experience platforms, are designed to lead to improved compliance, retention, and overall more predictable outcomes.

This presentation will share insights learned from Centros' deployment of its mobile engagement platform during clinical trials and examine how these can be applied to improve protocol design and overall patient centricity. The presentation will also explore how Centros' rapid prototyping capability can be used to inform this process in real-time, including a case study from a large pharmaceutical company.

Patient Engagement Solution: Pharmaceutical companies are increasingly focusing a wide array of strategies to improve patient / participant engagement, including support for online communities, focus groups, patient associations, etc. These efforts are invaluable in terms of advancing patient centricity and hearing the voice of the patient – particularly with the goal to incorporate these learnings into trial design and recruitment strategies.

Interestingly, however, these patient engagement strategies typically end at the point of trial design and recruitment. There are is almost no attention paid today to patient engagement and patient centricity during the trial, i.e., once the participant is enrolled. Pharma companies almost take for granted that patients will remain interested in the study and statistically factor for poor rates of med adherence and increasingly high rates of attrition -- a meaningful percentage of which could be avoidable.  A dedicated patient engagement strategy introduced during a trial could dramatically increase engagement and improve compliance, retention, and opportunities for data capture. Mobile apps are proven models for individual engagement; most individuals respond within 30 seconds to an SMS text for example and instinctively check email and/or social networking sites repeatedly throughout the day. As such, mobile apps and the smartphone itself presents a new medium to effectively engage participants. Centros has developed a mobile engagement platform to leverage this trend.

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