Introduction to adaptive designs and ICH E20
from The Effective Statistician - in association with PSI Hosted by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry
In this episode, I’m joined once again by my friend and frequent guest, Kaspar Rufibach, to talk about a topic that’s been around for decades but is gaining fresh attention thanks to the new ICH E20 draft guideline—adaptive designs in confirmatory clinical trials. Kaspar and I discuss why and when we should consider adapting a clinical trial, what kinds of adaptations are statistically valid and meaningful in a regulatory context, and why these designs—despite their efficiency—are still not used as often as they could be. We also dive into the statistical foundations behind adaptive designs, such as p-value combination methods and meta-analytic thinking, and explore how adaptive approaches can help us make faster and smarter decisions in drug development.
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