165 citations · 243 across the 12 of their papers we have counts for
14 papers · 1 filter
The Use of Covariate Adjustment in Randomized Controlled Trials: An Overview
Kelly Van Lancker, Frank Bretz, Oliver Dukes
There has been a growing interest in covariate adjustment in the analysis of randomized controlled trials in past years. For instance, the U.S. Food and Drug Administration recentl…
Generating the right evidence at the right time: Principles of a new class of flexible augmented clinical trial designs
Cornelia Dunger-Baldauf, Rob Hemmings, Frank Bretz +3
The past few years have seen an increasing number of initiatives aimed at integrating information generated outside of confirmatory randomised clinical trials (RCTs) into drug deve…
Confidence Sets for a level set in linear regression
Fang Wan, Wei Liu, Frank Bretz
Regression modeling is the workhorse of statistics and there is a vast literature on estimation of the regression function. It is realized in recent years that in regression analys…
Estimands and their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions
Kelly Van Lancker, Sergey Tarima, Jonathan Bartlett +8
The COVID-19 pandemic continues to affect the conduct of clinical trials globally. Complications may arise from pandemic-related operational challenges such as site closures, trave…
Connecting Instrumental Variable methods for causal inference to the Estimand Framework
Jack Bowden, Bjoern Bornkamp, Ekkehard Glimm +1
Causal inference methods are gaining increasing prominence in pharmaceutical drug development in light of the recently published addendum on estimands and sensitivity analysis in c…
Graphical approaches for the control of generalised error rates
David S. Robertson, James M. S. Wason, Frank Bretz
When simultaneously testing multiple hypotheses, the usual approach in the context of confirmatory clinical trials is to control the familywise error rate (FWER), which bounds the…