5 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…
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…
Estimating hypothetical estimands with causal inference and missing data estimators in a diabetes trial
Camila Olarte Parra, Rhian M. Daniel, David Wright +1
The recently published ICH E9 addendum on estimands in clinical trials provides a framework for precisely defining the treatment effect that is to be estimated, but says little abo…
Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic
R. Daniel Meyer, Bohdana Ratitch, Marcel Wolbers +15
The COVID-19 pandemic has had and continues to have major impacts on planned and ongoing clinical trials. Its effects on trial data create multiple potential statistical issues. Th…