Advanced group-sequential and adaptive confirmatory clinical trial designs, with R practicals using rpact

Published

September 3, 2023

Modified

September 3, 2023

1 Purpose of this document

Materials for the CEN 2023 pre-conference course Advanced group-sequential and adaptive confirmatory clinical trial designs, with R practicals using rpact, held in Basel on 3rd September 2023 by Kaspar Rufibach, Marc Vandemeulebroecke, Gernot Wassmer, and Marcel Wolbers.

2 Agenda of the event

09:00-09:10: Welcome
09:10-09:50: Theory: Efficient use of interim analyses (Kaspar)
09:50-10:30: Introduction to rpact, part 1 (Gernot), exercises (Kaspar & all, ex 1)
10:30-11:00: Coffee break
11:00-11:40: Theory: Introduction adaptive trials & sample size re-calculation (Marc)
11:40-12:30: Introduction rpact, part 2 (Gernot), exercises (Marc & all, ex 2)
12:30-14:00: Lunch
14:00-15:30: Theory: Multi-arm multi-stage designs (Marcel & Kaspar)
15:30-16:00: Coffee break
16:00-17:00: Introduction rpact, part 3 (Gernot), exercises (Gernot & all, ex 3-5)
17:00-17:15: Teaser: What can we expect from ICH E20? (Uli & Frank)
17:15-17:30: Final Q&A

3 Preparation prior to the event

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packageVersion("rpact")

4 Documents

Presenter Title Slides Markdown accompanying slides
Kaspar Rufibach Efficient use of futility and efficacy interim analyses in group-sequential designs X X
Marc Vandemeulebroecke Introduction adaptive trials & sample size re-calculation X
Gernot Wassmer Introduction to rpact X
Marcel Wolbers & Kaspar Rufibach Multi-arm multi-stage designs (MAMS) X
Frank Bretz and Uli Burger Adaptive trials: Some general considerations X