Speaker | Presentation as pdf |
---|---|
Franz König | Beyond RCTs - using historical data in pivotal clinical trials |
F König & P Bauer | Adaptive paediatric investigation plans |
Speaker | Presentation as pdf |
---|---|
Arvid Sjölander | Introduction to the field of causal inference |
Christian Bressen Pipper | Testing treatment equivalence in a survival setting |
Philip Hougaard | Recurrent events in the presence of a terminal event |
Bénédicte Delcoigne | Federated analyses |
Part | Downloads |
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Part 1: 17-18 January 2018 | Link to downloads for Part 1 |
Part 2: 31 January - 1 February 2018 | Link to downloads for Part 2 |
Link to guideline: ICH E9 (R1) addendum on estimands and sensitivity analysis
Speaker | Presentation as pdf |
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Agenda | Detailed program |
Frank Bretz | How the ICH E9 addendum around estimands may impact our clinical trials |
Søren Andersen & Helle Lynggaard | Implementation of estimands in Novo Nordisk |
Mette Krog Josiassen | Applying estimand strategies in schizophrenia |
Speaker | Presentation as pdf |
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Agenda | Detailed program |
Karsten Schmidt, Claus Bay & Merete Jørgensen | Biostatistics in the regulatory environment and the formation of DSBS in the 1990’s |
Ralf Bender, Institute for Quality and Efficiency in Health Care (IQWiG) | Evaluation of subgroup analyses in the framework of benefit assessment |
Erik Doffagne, CluePoints | Using central statistical monitoring to drive quality into clinical trials |
Nedjad Losic, Genmab | Two Bayesian designs for first-in-human trials in cancer |
Anders Malmberg, Ferring | A phase II trial with response-adaptive allocation |
Lasse Sluth, Lundbeck and Lars Endahl, Novo Nordisk | Regulatory interaction with Asia |