Designing Dermatology Trials That Actually Recruit: Overcoming Fragmentation, Cultural Barriers & Regulatory Constraints to Build Feasible, High-Quality Studies Across Europe
Dermatology trials, whether common indications like AD, psoriasis and acne, or rarer conditions with dispersed patients, face growing feasibility barriers. Fragmented healthcare systems, inconsistent standards of care, cultural differences influencing treatment-seeking behaviour, and increasingly stringent EMA expectations all hinder recruitment, retention, and data quality. This interactive workshop guides attendees through the practical realities of building trials that recruit reliably, retain diverse patients, and generate acceptable evidence across Europe. Through structured roundtables and shared problem-solving, participants will co-create tools for country selection, protocol feasibility, culturally adaptive engagement, and real-world patient support.
What attendees will gain: a realistic understanding of the operational, cultural and regulatory obstacles impacting both common and rare dermatology trials, with practical frameworks to improve feasibility, anticipate EMA expectations, and design studies that succeed despite fragmented systems and heterogeneous populations.
- How do we overcome Europe’s cultural and healthcare-system fragmentation when recruiting dermatology patients across both common and rare conditions?
- How should evolving confirmatory-study expectations (e.g., data robustness, acceptable endpoints, subgroup representation) reshape protocol design?
- What practical models exist for engaging elderly, offline, or underserved populations who cannot be reached through digital channels?
- How can we ethically support and incentivise participation when reimbursement rules and healthcare access vary widely by country?
- How do we harmonise standards of care and assessment tools across nations to reduce variability, especially when datasets are small or disease presentation is heterogeneous?