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Short Course 1: Advanced group-sequential and adaptive confirmatory clinical trial designs, with R practicals using rpact
Time:
Sunday, 03/Sept/2023:
11:00am - 12:30pm
Location:Lecture Room U1.111
Presentations
ID: 473 / Short Course 1: 1 Presentation Submissions - Featured Session Featured Sessions: Short Course Keywords: interim analyses; sample size re-calculation; multi-arm multi-stage designs
Advanced group-sequential and adaptive confirmatory clinical trial designs, with R practicals using rpact
Marcel Wolbers1, Kaspar Rufibach1, Gernot Wassmer2, Marc Vandemeulebroecke3
1Roche Pharma, Basel, Switzerland; 2rpact and University of Cologne, Germany; 3Novartis, Basel, Switzerland
This course is intended for biostatisticians from pharma and academia who are interested in learning more about advanced topics in group-sequential and adaptive clinical trial designs. Topics covered are the efficient use of interim analyses in group-sequential trials, an introduction to adaptive trials and sample size recalculation, the use of closed testing procedures for adaptive trials with multiple objectives, and multi-arm multi-stage designs. Examples from real clinical trials will be used throughout the presentations. We also aim to discuss operational aspects of implementing such designs in practice.
The course will be a mix of presentations and practicals using the R package rpact, a free and fully validated package for the design and analysis of group-sequential and adaptive trials. We will assume basic familiarity with group-sequential designs and R. Participants are asked to bring a laptop with R and rpact installed. It is the ambition of the instructors to make this course very interactive.
