6 papers
Communicating results in trials with multiple hypotheses or adaptive design features
Elina Asikanius, Marcel Wolbers, Mouna Akacha +8
Over time, clinical trials have increasingly incorporated complex design and analysis elements such as interim analyses, adaptations, multiple endpoints, and sophisticated multipli…
Statistical Methodology Groups in the Pharmaceutical Industry
Jenny Devenport, Tobias Mielke, Mouna Akacha +10
Research and Development is the largest budget position in the pharmaceutical industry, with clinical trials being a critical, yet costly and time-consuming component to inform dec…
Exhausting the type I error level in event-driven group-sequential designs with a closed testing procedure for progression-free and overall survival
Moritz Fabian Danzer, Kaspar Rufibach, Jan Beyersmann +1
In oncological clinical trials, overall survival (OS) is the gold-standard endpoint, but long follow-up and treatment switching can delay or dilute detectable effects. Progression-…
"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…
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…