Patient Centricity by Design Informed Consent Engagement Case Study

This case study outlines Medidata’s Patient Centricity by Design methodology, which aims to enhance the informed consent process in clinical trials by integrating patient insights into product development. The study highlights the challenges faced by patients in understanding informed consent documents, noting that up to 35% of patients decline participation due to comprehension issues. Medidata engaged with a Top 25 pharmaceutical client to compare a simplified informed consent form (ICF) with the standard template. The Patient Insights Board (PIB) conducted interviews and analyzed comprehension metrics over four weeks, providing actionable recommendations to improve the ICF. Key findings included the importance of document layout, the effectiveness of conversation-based consent processes, and the need for clearer language and visual aids. The PIB's recommendations led to a redesign of the informed consent forms, focusing on patient experience and comprehension, ultimately aiming to increase trial participation and adherence.