5 papers · 1 filter
Stratification in Randomised Clinical Trials for Rare Diseases and Analysis of Covariance: Some Simple Theory and Recommendations
Stephen Senn, Franz König, Martin Posch
A simple device for balancing for a continuous covariate in clinical trials is to stratify by whether the covariate is above or below some target value, typically the predicted med…
Selection Bias in Hybrid Randomized Controlled Trials using External Controls: A Simulation Study
Han Chang Chiam, Franz König, Martin Posch
Hybrid randomized controlled trials (hybrid RCTs) integrate external control data, such as historical or concurrent data, with data from randomized trials. While numerous frequenti…
Covariate adjustment for linear models in estimating treatment effects in randomised clinical trials. Some useful theory to guide simulation
Stephen Senn, Franz König, Martin Posch
Building on key papers that were published in special issues of Biometrics in 1957 and 1982 we propose and develop a three-aspect system for evaluating the effect of fitting covari…
Graph Based, Adaptive, Multi Arm, Multiple Endpoint, Two Stage Design
Cyrus Mehta, Ajoy Mukhopadhyay, Martin Posch
The graph based approach to multiple testing is an intuitive method that enables a study team to represent clearly, through a directed graph, its priorities for hierarchical testin…
A two-step approach for analyzing time to event data under non-proportional hazards
Jonas Brugger, Tim Friede, Florian Klinglmüller +3
The log-rank test and the Cox proportional hazards model are commonly used to compare time-to-event data in clinical trials, as they are most powerful under proportional hazards. B…