Manuel Wiesenfarth

Dec 8, 2023 | onlinelibrary.wiley.com | Silvia Calderazzo |Manuel Wiesenfarth |Annette Kopp-Schneider

1 INTRODUCTION While the adoption of Bayesian clinical trial designs is on the rise, particularly in early phase trials, additional reporting and “reasonable” control of frequentist operating characteristics has often been a requirement of regulatory authorities (Food & Drug Administration, 2010).

Aug 26, 2023 | onlinelibrary.wiley.com | Annette Kopp-Schneider |Manuel Wiesenfarth |Leonhard Held |Silvia Calderazzo

1 INTRODUCTION When trials can only be performed with small sample sizes as, for example, in the situation of precision medicine where patients cohorts are defined by a specific combination of biomarker and targeted therapy, borrowing information from historical data is currently discussed as an approach to improve the efficiency of the trial.