Snapshot

COUCH Health partnered with a top 10 biopharma company that were initiating a phase 3 clinical study in choroidal melanoma.

The Sponsor wanted to gain patient insights to refine and tailor their patient-facing study materials to be more appropriate, accessible, and inclusive for individuals with choroidal melanoma.

COUCH Health gathered insights from interviews and focus groups with people affected by choroidal melanoma to inform the development of these patient-facing study materials.

Problem

Choroidal melanoma often leads to vision impairment and visual disturbances, which will consequently impact the daily lives and accessibility needs of individuals living with the condition.

Patient-facing study materials for clinical studies are often designed without considering the needs and lived experiences of people with the condition, and their perspectives from different backgrounds and diverse communities.

The materials are often:

• Complex and difficult to understand
• The level of information and tone is not suitable for people who have received a life-changing diagnosis
• Accessibility needs are not considered

Strategy

COUCH Health proposed 3 strategies designed to gather feedback on the patient-facing study materials to ensure the upcoming phase 3 clinical study was accessible and inclusive of all people living with choroidal melanoma:

• In-depth interviews
• Online focus group with review pre-task
• COUCH Health review to assess accessibility and diversity, equity, and inclusion (DE&I) criteria.

Results

COUCH Health engaged with individuals with choroidal melanoma from the US and UK

Patients provided feedback on the patient-facing study materials focusing on:

• Tone of voice
• The level of information
• Document structure
• Accessibility
• Whether the purpose of the study was clear

Patient feedback on the materials revealed key themes:

• Quite overwhelming
• Not clear
• Ambiguous
• Hard to follow
• Left them with further questions
• Terms that required extra explanation

COUCH Health revised the materials with the patient feedback in mind while also applying best practices for DE&I, including:

• Language and terminology
• Patient-centric approaches
• Gender-inclusive language
• Cultural considerations
• Accessibility

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