Presentation for the U.S. Food and Drug Administration (FDA), March 3, 2022, 9:00am - 11:00am EST
Professor Gernot Wassmer, Ph.D. and Friedrich Pahlke, Ph.D.
Session Description: The focus of this webinar will be on adaptive group sequential designs and an R package to implement such designs and analyses. rpact is a comprehensive validated, open source, free-of-charge R software package for clinical research planning, design evaluation and analysis which:
- Enables the design of confirmatory adaptive group sequential designs
- Provides interim data analysis including early efficacy stopping and futility analyses
- Enables sample-size reassessment with different strategies
- Enables treatment arm selection in multi-stage multi-arm (MAMS) designs
- Provides a comprehensive and reliable sample size calculator.
- 9:05 - 9:30: Basic Concept
- 9:30 - 10:15: Sample Size Calculations, Simulation, and Analysis
- 10:15 - 10:45: Multi-Arm and Enrichment Designs
- 10:45 - 11:00: Q&A / Discussion
The interest was great: 128 participants from the FDA attended the presentation.