Navigating Global CTR–IVDR Trials: Real-World Challenges and Practical Lessons

Description: Drug trials normally include dozens of in vitro diagnostic tests (IVDs), which must be market approved based on local requirements and used within current intended purpose. When IVDs that are not fulfilling those requirements are used (and they do not comply with local in-house assay requirements either), combined drug-diagnostic trials/studies are typically needed. Combined drug–diagnostic studies are increasingly complex, particularly when IVD assays are used to screen, stratify, randomize, assign treatment, or monitor response. When an assay has a medical purpose in a trial, sponsors may face obligations under the IVDR alongside the CTR, creating overlapping documentation requirements, tight timelines, and operational challenges at shared sites.

This session takes a practical, interactive approach. Using real-world scenarios from global CTR trials and IVDR studies in Europe, the UK, and the US, the speakers will share experiences from multiple complex situations including combined studies. The discussion will explore common challenges, potential solutions, and lessons learned. While we may not have all the answers, participants will leave with practical insights and peer-tested strategies for navigating different types of trials.

A key theme is the collision of two worlds. Pharmaceutical and diagnostic teams often operate with different priorities and approaches. Aligning on protocols, endpoints, cut-offs, performance evaluation, risk controls, and submission strategies is critical for smooth trial conduct. We will discuss practical approaches for facilitating this alignment in global programs.

Topics include:
• When use of an IVD triggers IVDR obligations with special focus on situations in which activities qualify as performance studies
• Operational challenges in global trials, including coordination at shared sites, timeline alignment, and safety reporting
• Practical strategies to support alignment between pharmaceutical and diagnostic stakeholders
• Key regional considerations across Europe, the UK, and the US and common pitfalls in multinational trials

Participants will leave with practical takeaways, lessons from real cases, and the confidence that they are not alone in navigating complex combined studies.