Archives: Agenda

• Integrating patients into study design brings increased efficiency and focus – it’s about more than improving recruitment
• Practicalities of integrating patients based on real world experience

• Prioritising evidence that meaningfully advances regulatory and clinical credibility
• Leveraging publications, partnerships and existing data without inflating costs
• Practical tips and insights on structuring FDA interactions and study design to maximise impact with constrained resources

How it runs: A brief 10-minute “problem statement” is presented by the moderator, followed by a 30-minute collaborative “whiteboard” session where the group drafts a potential framework or solution. At the end each table will summarize their potential solutions.  

• Choosing when RWD can credibly support device regulatory questions
• Establishing data quality, provenance, and governance requirements
• Designing hybrid evidence packages combining trials and RWE

• Managing diagnostic and device complexity at site level
• Addressing sponsor–site misalignment early
• Practical tips for improving feasibility and retention