Clinical Trial Communications Playbook

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Process

Outcome

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Cross-disease Co-Design

How do you ensure every trial puts patients first?

US, EU · Breast cancer diagnostics

3 years
R&D program impact

The Challenge

A medtech company specialising in breast cancer diagnostics was entering the clinical trial space for the first time. Unlike established pharmaceutical companies with decades of trial experience, this company had no existing playbook for patient communications, informed consent processes, or participant engagement. They needed a best-practice document that could serve as a foundation for all future trials — adaptable, patient-centred, and grounded in real experience.

The Approach

Merakoi brought together 5 patient experts — including breast cancer survivors with clinical trial experience — across 3 virtual co-design workshops. The workshops were structured to build progressively: from mapping the patient journey through a clinical trial, to identifying communication pain points, to co-writing the actual playbook content. Patient experts did not just provide feedback on drafts; they shaped the structure, language, and priorities of the document from scratch.

The Outcome

The resulting clinical trial communications playbook became the cornerstone of the company’s R&D program over the next 3 years. It guided how the company designed informed consent forms, communicated with trial participants, and structured their patient engagement strategy across multiple studies. Marie Ennis O’Connor, one of the merakoi patient experts involved, described the project as “both personally fulfilling as a breast cancer survivor, and professionally fulfilling to help other patients.”

“The project allowed me to do work that was both personally fulfilling as a breast cancer survivor, but also professionally fulfilling to help other patients.”
— Marie Ennis O’Connor, merakoi Patient Expert (Patient Expert)
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