| | November 20188CIOReviewT he 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. 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. 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 By Kelly Franchetti, Vice President, Global Patient Insights and Engagement, ICON plc and Mapi GroupINCORPORATING THE PATIENT VOICE INTO TRIAL DESIGN: INSIGHTS SUPPORT RECRUITMENT SUCCESS
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