| | November 20189CIOReviewSponsors who fail to incorporate the voice of the patient into their trial designs and operations risk being disappointed in their recruitment resultsBarometer exercise, participants are busy moving and are less likely to fall in step with others. And third, participants enjoy it. This has proven to be the favorite activity in Empathy Workshops across patient populations. The ImpactThe combined quantitative and qualitative data gathered from Participation Barometers has been used to influence clinical trial design features, including treatment arms, visit schedules, and inclusion/exclusion criteria. In one application, patients with a rare form of cancer reacted very negatively in a Participation Barometer to a trial design that included just two arms: one for the investigational drug and one for the placebo. Interestingly, it was not the placebo that they objected to, but rather the lack of other types of chemo as options. In this form of cancer, there was no gold standard treatment, and patients wanted the option of moving across multiple types of therapy as needed. With this insight, the sponsor added other treatment arms to the protocol before sending it to the US Food and Drug Administration (FDA) for final review. This change prevented a basic design decision that might have had disastrous consequences for patient recruitment. When and How to Gather Patient InsightsListening to the voice of the patient through Empathetic Workshops takes time, but it need not add to the development timeline if the research is begun at the right time. If the research is to inform the protocol development, researchers should be engaged when the protocol is in a very preliminary, skeletal form so that information gleaned from patients can be used to shape the final design. Empathetic Workshops are also effective once the final protocol is defined, as they can be used to walk through the barriers and challenges, as well as to identify the motivators to participation.Developing, using, and interpreting effective research with patients and caregivers requires the expertise of a team of specialists, often including clinical specialists, health educators, learning strategists, adult learning designers, and clinical psychologists. Designing empathetic workshops requires the input of all of these specialties, including instructional design experts.Sponsors who fail to incorporate the voice of the patient into their trial designs and operations risk being disappointed in their recruitment results. The right research, conducted with patients and caregivers, and employed at the right time by professionals can ensure that patients are comfortable with the planned trial and can relate to trial-related materials. Kelly FranchettiFigure 1: Signs Used in the Participation Barometer
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