Impact of 2010 CHMP guideline on missing data in confirmatory trials

David Wright, Expert Statistical Assessor and Deputy Manager of Statistics and Pharmacokinetics Unit, MHRA

This talk will reflect on the main changes made to the missing data guideline. Feedback on changes that have been observed in the way Companies discuss their approach to handling missing data in meetings with regulatory agencies early in development will be provided. Also whether any change has been seen in the quality of regulatory submissions in terms of discussions of how missing data was handled will also be provided. The talk will end with suggestions for research areas where further work could be done to progress the field of handling missing data in regulatory submissions.