In this episode of "In the Interim…", Dr. Scott Berry interviews Dr. Andrew Thomson, owner and lead consultant of Regnitio. Thomson discusses his academic progression from mathematics at Cambridge to a Master’s at Southampton and advanced study with Prof. Sylvia Richardson at Imperial College, followed by doctoral work in cluster randomized trials at the London School of Hygiene and Tropical Medicine. He recounts the realities of regulatory roles, including contemplative study of data, working within multidisciplinary teams, and delivering regulatory assessments to senior committees. The episode contrasts EMA’s collaborative cross-country structure against the more centralized FDA process and explores methodological challenges faced by both. Scott and Andrew discuss regulatory expectations for interim analyses, the definition and metrics of trial complexity, and differing approaches to Type I error control across agencies. The conversation also covers the rapid adoption and adaptation of platform trials during COVID-19, and the impact on trial evaluation frameworks. Concluding, Thomson explains the motivation for launching Regnitio, emphasizing how regulatory perspective and multidisciplinary insight can support informed decision-making throughout clinical development.
Key Highlights
- Academic and professional pathway: Cambridge, Southampton, Imperial College, London School of Hygiene and Tropical Medicine
- Roles as a statistical assessor: analysis, collaborative review, expert panel presentations
- EMA vs. FDA: consensus-driven versus centralized approaches, harmonization challenges
- Trial complexity, Interim analyses, and diversity in regulatory interpretations
- Adoption and practicalities of platform trials during the COVID-19 response
- Consulting goals: integrating regulatory perspective and broad expertise for drug development decisions
For more, visit: https://www.berryconsultants.com/