During this afternoon session the E9 Efficacy guideline ‘Statistical principles for Clinical Trials’ issued by ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) will be discussed. Important statistical principles necessary to take into consideration when designing, conducting and analysing your clinical trial will be reviewed. Topics covered are primary and secondary variables, blinding, randomisation, type of comparison (superiority, equivalence, non-inferiority), interim analysis and early stopping, data analysis considerations (e. g. analysis sets, subgroups). Special attention is given to different types of randomisation and group-sequential designs. Students are assumed to be familiar with basic principles of statistical testing.

Universiteit Antwerpen (Campus Drie Eiken)
Universiteitsplein 1, 2610 Wilrijk
Friday 17/05: Room R.008