3 papers
stat.ME2026
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…
stat.OT2026
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…
stat.AP2026
Estimands and the Choice of Non-Inferiority Margin under ICH E9(R1)
Tobias Mütze, Helle Lynggaard, Sunita Rehal +3
Since the release of the ICH E9(R1) addendum on estimands, its application in non-inferiority trials has received far less attention than in superiority settings. A key conclusion…