Overview

Egality supported a global top-10 pharmaceutical company in designing and delivering Patient Councils to gather insights on an upcoming Phase 3 clinical trial in Alzheimer’s disease. The councils engaged patients and caregivers in assessing the study protocol to better align the trial with patient preferences, daily realities, and unmet needs.

Objectives:

• Obtain feedback and advice from people living with Alzheimer’s disease and their caregivers on key trial design elements, including study duration, visit frequency, and overall feasibility.
• Understand perceptions of specific trial procedures (e.g., IV infusions, observation periods, blood draws, ECG, MRI, PET scans, and lumbar punctures), and identify opportunities to improve comfort and mitigate concerns.
• Map the typical experience of clinical trial visit for both patients and caregivers, highlighting ways to improve flow, comfort, and preparedness throughout the day.
• Generate insights to inform participant support strategies within the trial design, such as travel assistance and clinic adaptations.
• Capture the perspective of caregivers to identify gaps in support, clarify their role, and explore strategies to improve their overall experience.

Outputs

Egality delivered two Patient Council sessions with eight participants in the US and two sessions with eight participants across the EU/UK.

To support the clinical study team, Egality delivered the following outputs:

• A detailed insights spreadsheet capturing key themes, recommendations and corresponding actions for the clinical study team.
• A set of 10 priority actions for immediate implementation, along with 64 additional recommendations to inform future studies.
• A comprehensive summary report, including an executive summary and an overview of each discussion theme, illustrated with direct quotes from participants.
• A visual journey titled, “A visit to the clinic during a clinical trial”, used to explore and gather feedback on participants’ end-to-end trial experience.
• A participant lay summary to share the insights gathered and highlight the prioritised actions taken as a result of their input.

“The pre meet information was comprehensive and I therefore knew what to expect and what was expected of me. I was perfectly at ease sharing my experiences and opinions. I just want to say that if you feel you would like more time for discussion, I would support that and would do it for free if you need to talk about it.”
– Feedback from a participant

Patient Engagement

To ensure effective and positive patient engagement, Egality developed a post-meeting survey aligned with on the Patient Focused Medicine Development (PFMD) criteria. Feedback from participants demonstrated high levels of satisfaction and trust in the process

• 75% of participants strongly agreed that they were approached with respect and openness when invited to participate, and that the contracting and consent information was clear and easy to understand.
• 100% of participants agreed or strongly agreed that they were provided with a dedicated point of contact and sufficient information before the session to feel prepared, supported, and comfortable raising questions or concerns.
• 100% of participants strongly agreed that the Patient Councils were facilitated in an inclusive manner that valued diverse experiences and created space for all voices.
• 100% of participants strongly agreed that the language and presentation materials used during the sessions were appropriate, easy to understand, and helped them follow the discussion topics.
• 100% of participants agree or strongly agreed that they understood how their insights would be considered by the pharmaceutical company in designing the clinical trial.

“I thoroughly enjoyed the experience; the meetings were excellently set up with more than enough information provided beforehand. All members were given opportunities to contribute.”
– Feedback from a participant

These results demonstrate the success of Egality’s patient-centred approach, ensuring that participants felt respected, informed, and supported in contributing meaningfully to trial design.

Outcomes

The findings gathered during this project will:

• Enhance the protocol design to reduce participant burden.
• Ensure the trial will be relevant, accessible, inclusive and patient-centred.
• Optimise the overall trial experience to support effective recruitment and sustained retention by ensuring participants have a positive trial experience.