The handling of missing data in clinical trials has become a crucial topic for clinical drug development in particular with respect to the regulatory process, as they are one of the most important sources of bias when analyzing clinical trials.
New methodologies and techniques have emerged like mixed-model repeated measures, multiple imputations, pattern-mixture models for longitudinal data as well as specific censoring rules and models for time to event data. As a consequence, regulatory agencies have published several documents related to the handling of missing data (e.g., Guideline on Missing Data in Confirmatory Clinical Trials EMA 02 July 2010).
Therefore, in order to achieve a successful drug registration, biostatisticians and clinical teams have to cope with the – often informative and dependant - nature of the missing data (not) observed in the trial.
The fourth conference of the European Statistical Forum is dedicated to theinvestigation, exploration as well as handling and analysis of missing data in clinical trials by presenting:
• State-of-the art statistical methodology.
• Real-life case studies of clinical trials showing how missing data can be handled and how they can impact trial results.
• Regulatory viewpoints on this topic.
Thereby the conference aims at promoting the exchange of experts in the field coming from academia and industry as well as regulators.
Insights will be provided on the newest trends and on how to apply techniques for pivotal clinical trials as well as regulatory aspects related to this topic.