Introduction to adaptive designs and ICH E20
The Effective Statistician - in association with PSI
Upcoming meetings and further discussion on E20
Alexander and Kaspar mention regulatory and ISCB meetings in Basel where E20 and adaptive designs will be discussed.
Why You Should Listen:
If you’ve ever wondered what adaptive designs really are, when they make sense, and how ICH E20 will influence our work as statisticians, this episode will give you a clear, practical overview.
You’ll learn:
✔ Why adaptive designs often save valuable time—and what organizational barriers keep teams from using them.
✔ What types of adaptations are possible and truly useful in confirmatory settings.
✔ How combining evidence across study stages works in principle.
Episode Highlights:
01:28 – Catching up with Kaspar
Kaspar returns to the podcast to dive into the topic of adaptive clinical trials.
02:34 – Why adapt?
We discuss the main motivation behind adapting a trial and when it’s worth the effort.
03:00 – Group-sequential designs
A quick look back at where adaptive concepts began and why they remain relevant.
06:03 – Practical adaptations
We touch on examples of adaptations that can make studies more flexible and efficient.
10:00 – Planning challenges
Kaspar shares how real-world constraints shape decisions around adaptive design.
15:06 – Why not more often?
We reflect on the cultural and operational reasons these designs are still less common than expected.
25:30 – ICH E20
An overview of what the new guideline covers and why statisticians should pay attention.
27:13 – Looking ahead
I share upcoming opportunities to continue this discussion at industry meetings in Basel.
29:13 – Closing thoughts
A reminder about the value of good planning and purposeful adaptation in clinical trials.
Resources and Links:
- ICH E20 (Draft): Adaptive Designs for Clinical Trials
- ICH E9(R1): Estimands and Sensitivity Analyses in Clinical Trials
- EFSPI Regulatory Workshop & ISCB Conference (Basel)
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