In this episode of "In the Interim...", Dr. Scott Berry dissects prevailing concepts of “clinically meaningful difference” in clinical trials focusing on progressive diseases.

Designing a group sequential phase 3 with a long time to final endpoint, using longitudinal modelling and Bayesian predictive probabilities for decision making at the interims.

Designing a trial with three arms compared to placebo and Active Comparator, using two endpoints: an early endpoint to compare to PBO for futility & arm selection in phase 2, and a late efficacy endpoint to compare against the AC.

Designing a platform trial to test several assets in the same indication that will become available over time.

Designing a phase 2 trial to determine for which of four rare tumours a treatment is effective. Looking at separate analyses, pooled analysis and using a hierarchical model to borrow across groups.

In this episode of "In the Interim…", Dr. Don Berry provides a detailed account of co-chairing the 1997 NIH consensus development conference on mammography for women in their 40s.