87 citations · 557 across the 33 of their papers we have counts for
5 papers · 1 filter
"6 choose 4": A framework to understand and facilitate discussion of strategies for overall survival safety monitoring
Godwin Yung, Kaspar Rufibach, Marcel Wolbers +2
Advances in anticancer therapies have significantly contributed to declining death rates in certain disease and clinical settings. However, they have also made it difficult to powe…
Clinical trials with interim analyses: Standardizing Terminology to increase clarity
Elina Asikanius, Benjamin Hofner, Lisa V. Hampson +5
Interim analyses for group-sequential decision making are prevalent in clinical trials. Methodology is well established and has been routinely implemented over the last decades. St…
Using shrinkage methods to estimate treatment effects in overlapping subgroups in randomized clinical trials with a time-to-event endpoint
Marcel Wolbers, Mar Vázquez Rabuñal, Ke Li +2
In randomized controlled trials, forest plots are frequently used to investigate the homogeneity of treatment effect estimates in subgroups. However, the interpretation of subgroup…
Balancing events, not patients, maximizes power of the logrank test: and other insights on unequal randomization in survival trials
Godwin Yung, Kaspar Rufibach, Marcel Wolbers +2
We revisit the question of what randomization ratio (RR) maximizes power of the logrank test in event-driven survival trials under proportional hazards (PH). By comparing three app…
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): summary of findings and a roadmap for the future of safety analyses in clinical trials
Kaspar Rufibach, Jan Beyersmann, Tim Friede +2
The SAVVY project aims to improve the analyses of adverse events (AEs) in clinical trials through the use of survival techniques appropriately dealing with varying follow-up times…