ICH E20: scope and purpose of the new guidance

A Conversation with Kaspar Rufibach

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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