6 papers
Principled type I error rate inflation in two-arm clinical trial designs with external control information borrowing
Silvia Calderazzo, Manuel Wiesenfarth, Vivienn Weru +1
External information borrowing is often considered in order to improve a clinical trial's efficiency. The Bayesian approach borrows such external information by specifying an infor…
Large Sample Inference with Dynamic Information Borrowing
Sergey Tarima, Silvia Calderazzo, Mary Homan
Large sample behavior of dynamic information borrowing (DIB) estimators is investigated. Asymptotic properties of several DIB approaches (adaptive risk minimization, adaptive LASSO…
Information borrowing in Bayesian clinical trials: choice of tuning parameters for the robust mixture prior
Vivienn Weru, Annette Kopp-Schneider, Manuel Wiesenfarth +2
External data borrowing in clinical trial designs has increased in recent years. This is accomplished in the Bayesian framework by specifying informative prior distributions. To mi…
Simulating and reporting frequentist operating characteristics of clinical trials that borrow external information
Annette Kopp-Schneider, Manuel Wiesenfarth, Leonhard Held +1
Borrowing of information from historical or external data to inform inference in a current trial is an expanding field in the era of precision medicine, where trials are often perf…
Robust incorporation of historical information with known type I error rate inflation
Silvia Calderazzo, Annette Kopp-Schneider
Bayesian clinical trials can benefit of available historical information through the elicitation of informative prior distributions. Concerns are however often raised about the pot…
Coping with Information Loss and the Use of Auxiliary Sources of Data: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions
Silvia Calderazzo, Sergey Tarima, Carissa Reid +9
Clinical trials disruption has always represented a non negligible part of the ending of interventional studies. While the SARS-CoV-2 (COVID-19) pandemic has led to an impressive a…