The Effective Statistician - in association with PSI

Introduction to adaptive designs and ICH E20


Listen Later

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)
  • 🔗 The Effective Statistician Academy – I offer free and premium resources to help you become a more effective statistician.

    🔗 Medical Data Leaders Community – Join my network of statisticians and data leaders to enhance your influencing skills.

    🔗 My New Book: How to Be an Effective Statistician - Volume 1 – It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.

    🔗 PSI (Statistical Community in Healthcare) – Access webinars, training, and networking opportunities.

    Join the Conversation:
    Did you find this episode helpful? Share it with your colleagues and let me know your thoughts! Connect with me on LinkedIn and be part of the discussion.

    Subscribe & Stay Updated:
    Never miss an episode! Subscribe to The Effective Statistician on your favorite podcast platform and continue growing your influence as a statistician.

    ...more
    View all episodesView all episodes
    Download on the App Store

    The Effective Statistician - in association with PSIBy Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

    • 4.4
    • 4.4
    • 4.4
    • 4.4
    • 4.4

    4.4

    9 ratings


    More shows like The Effective Statistician - in association with PSI

    View all
    Stuff You Should Know by iHeartPodcasts

    Stuff You Should Know

    78,277 Listeners

    Freakonomics Radio by Freakonomics Radio + Stitcher

    Freakonomics Radio

    32,075 Listeners

    Planet Money by NPR

    Planet Money

    30,683 Listeners

    Hidden Brain by Hidden Brain, Shankar Vedantam

    Hidden Brain

    43,540 Listeners

    Pivot by New York Magazine

    Pivot

    9,499 Listeners

    JAMA Clinical Reviews by JAMA Network

    JAMA Clinical Reviews

    498 Listeners

    HBR IdeaCast by Harvard Business Review

    HBR IdeaCast

    1,827 Listeners

    Page 94: The Private Eye Podcast by Page 94: The Private Eye Podcast

    Page 94: The Private Eye Podcast

    338 Listeners

    The Peter Attia Drive by Peter Attia, MD

    The Peter Attia Drive

    8,190 Listeners

    The Journal. by The Wall Street Journal & Spotify Studios

    The Journal.

    6,056 Listeners

    Huberman Lab by Scicomm Media

    Huberman Lab

    29,158 Listeners

    Biotech Hangout by Daphne Zohar, Josh Schimmer, Brad Loncar, Tim Opler & more

    Biotech Hangout

    20 Listeners

    The Rest Is Politics by Goalhanger

    The Rest Is Politics

    3,148 Listeners

    DER TRUMP EFFEKT  –  ZDF auslandsjournal – Der Podcast by ZDF

    DER TRUMP EFFEKT – ZDF auslandsjournal – Der Podcast

    11 Listeners

    Die Peter Thiel Story by Deutschlandfunk

    Die Peter Thiel Story

    27 Listeners