Incorporating the Patient Voice into Trial Design: Insights Support Recruitment Success
The expression “patient-focused drug development” can sound redundant, as, of course, life sciences companies design their products for patients. Still, the patient voice can get lost in the development process when sponsors approach clinical trials from a purely scientific standpoint. Should they neglect to “ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation,” their assumptions on the acceptability of trial design and the appeal of materials can significantly miss the mark. Such trials can fail to resonate with, or meet the needs of, the targeted patient population.
Avoiding such an outcome by infusing the patient voice into trial planning and operation has become a common theme in life sciences R&D that cuts across geographic regions, phases of development, and therapeutic areas. There are many creative and effective tools and methodologies—beyond focus groups—for digging deep and getting actionable feedback from patients and caregivers.
The Empathetic Workshop
The key to obtaining meaningful insights is to engage patients directly, such as through a workshop, which is one of many robust methodologies that should be designed specifically to address the sponsor’s particular business need. Creative interactivity is essential to drawing out participants. One interactive exercise that has proven effective (and popular with participants) is the “Participation Barometer.” It can be used to gather feedback on critical trial design features, reveal patient preferences related to recruitment methods and communication preferences, determine patient needs related to retention, and better understand patient decision making.
Sponsors who fail to incorporate the voice of the patient into their trial designs and operations risk being disappointed in their recruitment results
Here’s how it works. Participants are asked to react to statements read aloud to them, such as “I would join the trial, even if there was a chance I’d be on placebo” or “I would be more willing to join the trial if I saw an advertisement online.” Participants then “vote with their feet” by moving to stand under signs posted on the walls labeled “strongly disagree,” “disagree,” “neutral,” “agree,” and “strongly agree.” (See Fig. 1.) Participants then take part in an in-depth discussion of each statement and their vote, a processes that supports the collection of robust qualitative data as well.
Figure 1: Signs Used in the Participation Barometer
This approach has several significant advantages over the traditional focus group format. First, such interactivity and physical movement encourages people to open up and tends to elicit honest answers. Second, it eliminates the “leader of the pack” mentality in which an outspoken participant sways the views of others in the room. During the Participation Barometer 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 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 Insights
Listening 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.
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