Investigating the impact of data monitoring committee recommendations on the probability of trial success

• Published in: Journal of biopharmaceutical statistics pp. 1 - 17
• Main Authors: Rondano, Luca, Saint-Hilary, Gaëlle, Gasparini, Mauro, Vezzoli, Stefano
• Format: Journal Article
• Language: English
• Published: England 08.12.2024
• Subjects: Assurance; interim analysis; hybrid Bayesian/frequentist design; group sequential design; probability of success; futility; efficacy

Determining the probability of success of a clinical trial using a prior distribution on the treatment effect can significantly enhance decision-making by the sponsor. In a group sequential design, the probability of success calculated at the design stage can be updated to incorporate the informatio...