DIA 2018
June 24-28, 2018
Boston
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W-23: Participation Barometer: Learn What Influences Patient Decision-Making





Poster Presenter

      Kelly Franchetti

      • Vice President, Global Head Patient Insights and Strategy
      • YPrime
        United States

Objectives

Utilize an interactive patient exercise to obtain valuable input from patients on clinical trial design features and to optimize clinical trial operations.

ORAL PRESENTATION: 12:40PM

Method

In 5 in-person, interactive workshops with 4 distinct patient populations, patients were actively engaged in a “participation barometer” activity designed to obtain insight as it relates to clinical trial decision-making.

Results

Up to 12 stimuli were created to assess reactions to specific plans for upcoming phase II and phase III clinical trials. The stimuli were read to participants, who then "voted with their feet" by standing under signs labeled "strongly agree," "agree," "neutral," "disagree," and "strongly disagree." The reactions to each stimuli were recorded. In-depth discussion of each stimulus followed, allowing for collection of robust qualitative data, as well. The combined quantitative and qualitative data were utilized to influence clinical trial design features, including treatment arms, visit schedules, target populations, and inclusion/exclusion criteria. Data also contributed to decision-making related to the design and development of recruitment methods and materials, as well as patient retention strategies and tactics. In several instances, patient data (both quantitative and qualitative) did not match the reactions anticipated by the Sponsor or the researchers, so the impact on trial design and operations was significant.

Conclusion

Sponsor and researcher assumptions related to the acceptability of planned trial design and operations can significantly miss the mark, resulting in trials that fail to resonate or meet the needs of the targeted patient population. Activities such as the "participation barometer" can be used to test these assumptions and gather data to support changes in trial design; these proposed changes can then be further tested with larger patient groups and presented to healthcare providers to test acceptability with those audiences. Additionally, interactive exercises such as this allow Sponsors to plan for optimal clinical trial operations, from recruitment methods and materials to strategies and tactics designed to fully engage patients throughout the course of the trial. Sponsors who engage patients early in the planning process for phase II and III clinical trials can design a trial protocol and operations plan that resonates with the targeted patient population and has an increased likelihood of success.