In this conversation, Karen Minor explores what makes IVD (in vitro diagnostic) studies fundamentally different from traditional medical device trials and why generating trust in diagnostic results is just as important as demonstrating test performance. She discusses the critical role specimen procurement plays in study success, how evidence generation must align with real-world clinical use, and why evolving technologies like AI and decentralized diagnostics are reshaping how IVD studies should be designed. Karen emphasizes that successful sponsors are those who build studies around how diagnostics are actually used, not just how they're evaluated in controlled research settings.
Key Takeaways:
- IVD studies answer a different question. Rather than asking whether a treatment improves patient outcomes, IVD studies must demonstrate that clinicians can trust the accuracy and clinical relevance of a test's results.
- Specimen strategy can make or break a study. Access to the right specimens, collected at the right sites and at the right time, is often the biggest determinant of study timelines and overall success.
- Real-world performance matters. Strong IVD studies generate evidence that a test will perform consistently across intended-use populations and in routine clinical practice, not just under controlled laboratory conditions.
- Study design must evolve with technology. AI-enabled and decentralized diagnostics require sponsors to consider data quality, algorithm bias, user variability, and long-term performance when designing clinical studies.
- The future of diagnostics is built on trust. As diagnostic technologies become more complex, successful studies will validate not only the test itself but the entire ecosystem of software, data, workflows, and users that supports reliable clinical decision-making.