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Case Study: A Patient Partner Workshop Impacts Trial Design

Overview
A sponsor of a clinical trial in breast cancer sought to understand patients’ attitudes and beliefs related to key aspects of trial design, as well as barriers and motivators to participation.

Objectives
Identify:

  • Current patient perceptions and expectations of breast cancer treatment
  • Trusted sources of information
  • Drivers of decision making and key influencers
  • Patient’s willingness and ability to proactively engage in a conversation with their physician
  • Significant knowledge gaps

Method
Laying the groundwork: To ensure we created a workshop that was relevant to the patient population, we reviewed current literature, patient research conducted by the sponsor, and online patient resources and social media, through the lens of our experience and expertise. We designed a wellinformed workshop with an understanding of what these resources could tell us about:

  • How a person experiences a condition clinically
  • Behavioral barriers and motivations
  • Influencers
  • Factors that may affect learning and comprehension

Then, we consulted with advocacy leaders to confirm our findings and partnered with them to identify participants for the workshop.

Patient Partner Workshop
Mapi created a one-day in-person workshop of a targeted group of women with breast cancer. Interactive, hands-on activities were designed to facilitate authentic exchanges between the patients and the sponsor. This open dialogue was the key to uncovering actionable insights, ensuring the sponsor could implement what was learned.

Outcomes Based on Actionable Insights
Based on feedback from the Patient Partner Workshop, the sponsor added an additional treatment arm to their trial. They are using findings from this workshop in their discussion with government regulators.

Patients expressed concern over two features of the trial design. The first was not able to be changed, however the sponsor will provide additional education and justification to potential participants. The second was a misunderstanding that the sponsor will clarify within the protocol and patient materials.

Recognizing that existing online sources of trial information are confusing and overwhelming to this group of patients, the sponsor committed to creating their own source of trial information, utilizing these learnings.

As the treating oncologist was identified as a primary and trusted source of information, the sponsor planned to emphasize efforts to engage them in recruitment and education for this trial.

Insights gained into operational aspects of the trial informed a second Patient Partner Workshop to formulate tactical recommendations for the trial.

Sponsor Feedback
"Incredible workshop"
"Very successful"
"A powerful experience"

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